HIV Self-testing Kits Research Articles

P-513. Recruitment Challenges for Youth HIV Pre-exposure Prophylaxis (PrEP) Research

Abstract Background Recruitment for youth-focused PrEP studies among sexual and gender minority (SGM) youth is a challenge. We report on recruitment strategies and lessons learned from a youth TelePrEP study in Colorado.Table 1:Recruitment strategies used for youth PrEP study Methods Youth assigned male at birth, ages 18-24 years, eligible for PrEP using FTC/TAF, and at risk for HIV in Colorado were recruited to participate in a pilot feasibility trial of PrEP services provided via telehealth. Participants agreed to be seen via telehealth and to obtain initial lab testing at one of seven sites located throughout the state. PrEP medications were offered free for up to 12 months via in-person pick up or mail delivery. Youth were able to enroll and receive clinical care regardless of insurance type. HIV self-test kits were available via mail for follow up testing. Participants received $25 at time of enrollment. Recruitment methods were informed by two electronic youth surveys (N= 375 total), student young adult advisors, youth PrEP providers, and research team experience in youth HIV treatment and prevention studies.Figure 1:Recruitment Flow Chart Results A total of 319 individuals completed an online recruitment survey of which 44 (14%) were eligible and 21 (48%) of those enrolled between January 2023 and March 2024 out of a target of 100 study participants. (Figure 1) An estimated 107,500 individuals received at least one form of study recruitment. (Table 1) Direct recruitment occurred through adolescent clinics (including family planning/STI, transgender care, adolescent primary care, and youth HIV clinics) and pediatric primary care offices via primary care provider referral (N=4 enrolled). Community recruitment was done through SGM youth-serving organizations, community events, during community HIV education sessions (N=4 enrolled). On-line recruitment utilized social media (including targeted ads and sponsored influencers), dating apps, and survey outreach (N=6 enrolled). (Figure 2) Dating apps and social media were the most common recruitment strategies among eligible participants.Figure 2:Examples of Youth TelePrEP Recruitment Materials Conclusion Despite a multipronged approach to recruitment of SGM youth for a study on youth TelePrEP, recruitment was below targets. Additional innovation and evaluation of strategies are needed to not only increase recruitment to youth PrEP studies but also youth PrEP services. Disclosures Lisa Abuogi, MD, MS, Gilead Sciences: Grant/Research Support Alexander Limas, MSW, Gilead Sciences: Grant/Research Support AJ De La Garza, BSW, Gilead Sciences: Grant/Research Support Katherine Leonard, MSN, FNP-BC, Gilead Sciences: Grant/Research Support Sam Gallegos, BS, Gilead Sciences: Grant/Research Support

P-476. Pilot Implementation of HIV Self-Testing in Ghana: Analysis of the Community-Based Demand Generation Approach

Abstract Background Under the auspices of the Ministry of Health (MoH) and National AIDS/STI Control Programme (NACP), Ghana piloted an HIV Self-Testing (HIVST) project in 2023. The implementation took place in 50 HIV high burden districts and it was spearheaded by Ghana HIV and AIDS Network (GHANET), a grassroots civil society organization (CSO) with membership across the country. This paper examines the strategies and outcomes of the project which was sponsored by the Global Fund and currently being expanded as part of Grant Cycle Seven (GC7) implementation from 2024 to 2026. Methods One hundred and fifty (150) volunteers from 50 community-based organizations (CBOs) were trained to distribute ORAQUICK HIVST kits to local residents in the selected districts. Video instructions on the effective use of the test kits (produced in English and six different Ghanaian dialects) were made available to persons who voluntarily received the kits. Through an online portal (GHANET Information Management System (GIMS)) data about the distributions were recorded. Follow-ups were conducted to ascertain, among others, how the kits were used. The data was quantitatively analyzed and descriptive statistics was used to summarize the data using Statistical Package for Social Science (SPSS v.28). Results A total of 123,088 ORAQUICK HIVST kits were distributed (with follow-ups) to 73,853 (60%) females and 49,235 (40%) males. Young people aged 20 – 24 received the highest number of kits totaling 28,790 which is about 23%, followed by those aged 25 – 29 who received 25,006 which is about 20% and those aged 30 – 34 who received 17,460 which is about 14%. A total of 422 persons comprising 304 (72%) females and 118 (28%) males self-reported their results as reactive. Of this number, 329 persons comprising 72% of females and 28% of males were confirmed positive. And, out of that number, 202 persons comprising 73% females and 27% males were successfully initiated on antiretroviral therapy (ART) in health facilities. Conclusion Male participation of 40% in the testing exercise was encouraging as it above the national average of 20% . It is therefore recommended that in Ghana, HIVST should, particularly, be targeted men. Disclosures All Authors: No reported disclosures

Feasibility, acceptability and preliminary effects of a social network-based, peer-led HIV self-testing intervention among men in two Ugandan fishing communities, 2022

BackgroundSocial network-based interventions can improve uptake of health interventions. However, limited evidence exists on their feasibility and acceptability in fishing community settings. We assessed the feasibility, acceptability and preliminary effects of a social network-based, peer-led HIV self-testing (HIVST) intervention among men in Uganda.MethodsThe PEer-led HIVST intervention for MEN (PEST4MEN) is a pilot intervention conducted among men in Kalangala and Buvuma districts. Baseline data were collected in July 2022 and follow-up data in September 2022. The intervention was implemented through 22 trained lay men (“peer-leaders”) who received training in HIVST use and distribution processes and requested to refer at least 20 male members from their social networks for study eligibility screening. To be eligible, men had to be aged 15 years or older with unknown or HIV-negative status. After the baseline interview, men were requested to pick two oral fluid-based HIVST kits from their peer-leaders. The intervention was deemed feasible if peer-leaders gave-out > 80% of the kits and acceptable if > 80% of the kits’ recipients used them to self-test for HIV. At the follow-up interview, newly diagnosed HIV-positive men were asked if they had linked to HIV care. Data were descriptively analyzed using STATA version 16.0.ResultsOf 475 screened men, 400 (84.2%) met the eligibility criteria and completed the baseline interview. Of these, 56.7% (n = 227) were engaged in fishing or fishing-related activities. At follow-up, 361 men (90.2%) were interviewed; 98.3% (n = 355) received at least one kit from their peer-leaders. Nearly all (99.1%, n = 352) kits’ recipients used them to self-test for HIV. Of the 352 HIV self-testers, 51 men (14.5%) had reactive (positive) HIV self-test results. Nearly one-third of the HIV self-tested men (31.4%, n = 16) were first-time HIV-positive testers. Of these, 87.5% (n = 14) went for confirmatory HIV testing, 50.0% (n = 7) were confirmed as HIV-positive and 71.4% (n = 5) were linked to HIV care.ConclusionOur peer-led HIVST intervention was feasible and acceptable and identified newly diagnosed HIV-positive men who were linked to HIV care. However, while these results are promising, we recommend additional research in a randomized controlled trial prior to the eventual roll-out of this intervention.Trial registrationClinicalTrials.Gov: NCT05685498 (retrospectively registered on January 17, 2023).

Factors associated with HIV self-testing and PrEP use among Nigerian youth: Baseline outcomes of a pragmatic, stepped-wedge, cluster-randomized controlled trial

IntroductionAdolescents and young adults (AYA, 14–24 years) bear a disproportionate burden of new HIV infections in Nigeria and are more likely to have worse HIV outcomes compared to other age groups. However, little is known about their access to recommended sexual health care services, including HIV self-testing (HIVST), sexually transmitted infections (STI) testing, sexual behavior patterns, awareness and or access to pre-exposure prophylaxis (PrEP), and overall risk for HIV. MethodsWe present a baseline analysis of the 4 Youth by Youth randomized controlled trial aimed to evaluate the uptake and sustainability of crowdsourced HIVST strategies led by and for young people across 14 states in Nigeria. None of the participants had received intervention at the time of completing this self-reported behavioral survey. We conducted a descriptive analysis to summarize participants' characteristics, sexual behavior, HIV testing, STI testing, and knowledge of PrEP and use across the study sample of the AYAs. We conducted a chi-square test, and the level of significance was set at ≤0.05. ResultsA total of 1551 participants completed the baseline survey comprising males (777, 50.1 %) and females (774, 49.9 %). The majority (77 %) of the participants were students at enrollment. Very few of the participants had ever tested for syphilis, 47 (3.1 %), gonorrhea, 49 (3.2 %), chlamydia, 31 (2.0 %), and hepatitis B, 106 (6.9 %). 678 (43.8 %) of the participants reported to be sexually active at the time of enrolment into the study, of which about 38 % of them engaged in condomless sex. Paying for sex, alcohol use, and drug use are all significant sexual behaviors (p < 0.01). Only 14 (1 %) have ever used PrEP. 481 (31.4 %) have ever tested for HIV, and 104 (6.8 %) have ever used an HIV self-testing kit at baseline. 457 (38.6 %) were eligible for PrEP. ConclusionsHIVST and STI uptake were low at baseline among the AYA in this study. Most AYAs also do not receive recommended sexual health care services, including STI testing services. This underlines the need for interventions to increase the uptake of HIV/STI prevention services among Nigerian AYA.

Evaluating the effectiveness of oral HIV self testing according to distribution models in Cameroon

Innovative strategies such as HIV self-testing (HIVST) are useful for identifying hard-to-reach people living with HIV/AIDS (PLHIV), especially in developing settings where considerable gaps still exist in reaching the first 95% UNAIDS target. We evaluated the effectiveness of HIVST in Cameroon using several distribution models and investigated the predictors of HIV seropositivity among self-testers. The study was conducted from 2021 to 2022 in three regions in Cameroon. HIVST kits were distributed according to 5 distribution models: antenatal, postnatal, maternal and child clinics (ANC/PNC/MCH); partners of PLHIV; workplace; community and HIV-testing services (HTS). Overall, 42,687 people received oral HIVST kits, among whom 15.6% were HIV first-testers. Approximately 85% reported on the test outcome; 2.3% (n = 825) were reactive, and 75.8% came for test confirmation. After the confirmation test, a concordance of 85% was found with the national algorithm. Overall, the HIV seroprevalence was 1.5% [95% CI: 1.4–1.6]; ANC/PNC/MCHC: 1.9%, partners of PLHIV: 6.9%, workplace: 0.5%, community: 0.1% and HTS: 7.0%, p < 0.001. The positivity rate among first-testers was 1.2%. Youths < 25 years had a lower seroprevalence (0.4%) than older people (2.6% and 2.7% for those aged 25–39 and those aged ≥ 40 years, respectively), p < 0.001. Seropositivity was negatively associated with secondary distribution, workplace model, community model and age < 25 years. On the other hand, partners of PLHIV model, HTS model, female sex and first-time-testers were positively associated with seropositivity. In Cameroon, oral HIVST is an effective approach for identifying undiagnosed PLHIV, especially when using ANC/PNC/MCHC, partners of PLHIV and HTS distribution models. However, to ensure the successful scale-up of HIVST in Cameroon, guidelines should be revised to fine-tune the target populations for HIVST and optimize the use of resources.

Towards Ending AIDS: The Additional Role of HIV Self-Testing in Thailand.

In 2022, 10% of an estimated 560,000 people living with HIV in Thailand were unaware of their HIV status. A well-established HIV program is a solid platform for integrating HIV self-testing (HST) as part of efforts to end AIDS. We analyzed how HST was integrated into the national HIV program and became a benefit package. In 2015, the National AIDS Prevention and Alleviation Committee included HST as a strategy to end HIV/AIDS by 2030. This led to collaboration between the Department of Disease Control (DDC), Food and Drug Administration (FDA), and partner networks, including civil society organizations, to amend policy regulations, allowing HIV testing outside health care facilities and facilitating HST registration. By 2024, 4 HST commercial products were registered by the Thai FDA. In 2020, the DDC launched pilot programs distributing HST kits through private pharmacies in Bangkok and online platforms. Preliminary findings showed feasibility in reaching key populations and adolescents. In 2023, HST was included in the Universal Health Coverage benefit package, providing free access to all citizens. Guidelines, e-learning, public awareness campaigns, and a reimbursement system of HST were developed and implemented. By September 2024, over 166,000 users had received HST kits. Leadership, scientific evidence, feasibility testing through pilots, regulatory adjustments, licensing, price negotiations by the National Health Security Office, and stakeholder and community engagement were key to the program's success. A nationwide distribution network through public and private health care facilities, including pharmacies, was a key enabling factor for HST delivery. HST is an additional intervention to increase awareness of HIV status and a key component in Thailand's effort to end HIV/AIDS.

Never tested for HIV among men who have sex with men, Hanoi, Vietnam: correlates and missed opportunities.

Introduction: Understanding levels of HIV testing among populations at risk for acquisition is essential to meeting the goal of the United Nations that 95% of individuals living with HIV know their status. This study assessed HIV testing prevalence among men who had sex with men (MSM), characteristics of MSM who have never tested for HIV, and missed testing opportunities in Hanoi, Vietnam.Methods: We measured the prevalence of never testing for HIV and missed opportunities for testing in the baseline data of a cohort study of MSM recruited in 2017-2019 in Hanoi. Logistic regression analysis characterized MSM who had never tested prior to cohort participation.Results: Of 1,893 MSM enrolled in the cohort, 39.4% had never previously tested for HIV. MSM with children (aOR 1.75, 95% CI 1.09-2.82) and those who did not know or remember having a male partner living with HIV (aOR 1.41, 95% CI 1.07-1.84) were more likely to have never tested. Older age, university education, higher income, and having a male partner living with HIV were associated with a lower likelihood of never having been tested. The most common missed testing opportunities to test MSM who had never been tested were when receiving free condoms from health educators (35.3%), testing for other sexually transmitted infections (STIs) (23.3%), reporting their MSM status to healthcare workers (16.4%), and receiving an STI diagnosis (13.0%). The most common barriers identified by MSM who had never tested were fear of seeking health care due to their sexual orientation (82.7%) and having been refused healthcare due to their sexual oreitnation (76.2%).Conclusions: Facilitating provider-initiated HIV testing in STI clinics and other healthcare services, community-based testing, and HIV self-test kits should enhance HIV testing options for young MSM, especially those with lower education and income.

An innovation bootcamp model for developing youth-led HIV self-testing delivery strategies in Nigeria: post-designathon capacity building.

Many designathons, hackathons, and similar participatory events suffer from minimal training and support after the events. Responding to this need, we organized a health innovation bootcamp: an intensive, team-based apprenticeship training with research and entrepreneurial rigor among young people in Nigeria to develop HIV self-testing (HIVST) delivery strategies for Nigerian youth. The purpose of this paper was to describe an innovation bootcamp that aimed to develop HIVST delivery strategies for Nigerian youth. The four-week, in-person innovation bootcamp, informed by youth participatory action research and comprised a series of workshops, took place in Lagos, Nigeria. The goal was to build research and entrepreneurial capacities among young people to develop and implement HIVST strategies. A qualitative content analysis informed by an adapted World Health Organization's HIVST delivery framework explored key elements of the proposed HIVST service delivery strategies developed at the bootcamp. Twenty participants, aged 18-24 years, from five teams completed the innovation bootcamp. The five teams developed HIV service delivery strategies that included an element of repacking HIVST kits to make them more appealing to young people. Other strategies that emerged included leveraging community engagement platforms (e.g., vocational skills training and youth community events) to promote HIVST, and the use of reward-referral system to encourage HIVST uptake among young people. All strategies included ways to ensure privacy protection for recipients of the HIVST delivery package. This study demonstrated the feasibility and acceptability of the health innovation bootcamp model to create HIVST designed for and led by young people. This suggests a way to build capacity after participatory events to sustain youth-led research, which could have implications for post-designathon training.

Assessment of the acceptability and detection rate of HIV self-testing in Nigeria: a systematic review and meta-analysis

BackgroundHIV remains a major public health challenge in Nigeria, with significant gaps in testing coverage caused by stigma, limited healthcare access, and logistical issues, highlighting the need for enhanced HIV control efforts. HIV self-testing presents a promising solution to overcome these barriers; however, there is a lack of systematic review and meta-analysis on its effectiveness within Nigeria for evidence-based medicine decision.ObjectivesTo systematically assess the acceptability and detection rate of HIV self-testing in Nigeria.MethodsStudies conducted in Nigeria on HIV self-testing with or without comparison to other HIV tests were included. The primary outcomes were the detection rate of new HIV cases and acceptability (uptake) rate for HIV self-testing. Electronic databases (PubMed/Medline, Web of Science, Scopus, CINAHL, and Cochrane Library) and Google Scholar were searched. Pooled estimates were calculated using a random-effects model. Heterogeneity was analyzed using the I2 test, and risk of bias was assessed with the Hoy and colleagues’ scale. The PROSPERO registration number: CRD42023479752).ResultsEight studies, encompassing 7556 participants, met the inclusion criteria. The overall risk of bias was low. The detection rate of HIV self-testing for new HIV cases was 25.78% (95% CI 0.90–50.66, I2:100.0), acceptability (uptake) rate was 56.92% (95% CI: 26.54–87.30, I2:100.0), and repeat testing rate was 20.10% (95% CI − 11.44–51.65, I2:100.0).ConclusionsThe use of HIV self-testing test kits in Nigeria showed a high detection rate of new HIV cases, moderate acceptability, but low repeat testing rates. Larger, higher-quality studies are essential to explore the broader impact of HIV self-testing on reducing HIV incidence in Nigeria.

Linkage to care and prevention after HIV self-testing: a systematic review and meta-analysis.

Effective linkage to prevention and care is a crucial step following HIV testing services. This systematic review aimed to determine the proportion of individuals linked to prevention and care after HIV self-testing (HIVST) and describe factors associated with linkage. Following PRISMA guidelines, a comprehensive search across eight databases (2010-October 2023) identified studies on linkage to care after HIVST, defined as receiving a confirmatory test or initiating antiretroviral therapy (ART) if the self-test was reactive, and/or pre-exposure prophylaxis (PrEP) if the self-test was non-reactive. A random-effects meta-analysis summarized the findings and meta-regression explored study-level covariates, such as world region, population type and service delivery model, that might explain the between-study heterogeneity. From 10,071 screened studies, 173 were included in the meta-analysis. The majority of studies focused on key populations in Africa using unassisted, oral fluid-based HIVST kits. Among those with reactive HIVST results, 92% (95% confidence interval [CI]: 88-95) were linked to confirmatory testing (n = 124 studies), and 89% (95% CI: 84-93) of newly diagnosed individuals initiated ART (n = 88 studies). Overall, 84% (95% CI: 74-93) of self-testers were linked to care (n = 69 studies). However, only 9% (95% CI: 2-19) of individuals with non-reactive HIVST results were linked to PrEP services (n = 9 studies). Assisted HIVST was associated with higher linkage rates to confirmatory testing and ART initiation compared to unassisted testing. Meta-regression revealed that the type of delivery model for the HIVST kits influenced linkage and that individuals who obtained their HIVST kits through a social network-based approach (SNA) were more likely to be linked to confirmatory testing (adjusted odds ratio = 1.28 [95% CI: 1.10-1.50], p = 0.001) compared to non-SNA service delivery model. In the context of expanding HIVST services globally, we found that linkage to confirmatory testing and ART initiation after HIVST is generally high, particularly when assisted HIVST or SNA-based distribution is used. Strengthening timely linkage is vital for improving health outcomes, reducing HIV transmission and achieving the UNAIDS 95-95-95 goal. Ongoing research and collaboration with community-based organizations are needed to overcoming barriers and ensuring positive outcomes for those using HIVST. CRD42022357570.

Uptake and Acceptability of HIV Self-Testing Among Pregnant and Postpartum Women and Their Male Partners in Sub-Saharan Africa: Benefits, Challenges, and Delivery Strategies.

HIV self-testing (HIVST) offers a novel solution for increasing HIV testing among pregnant and postpartum women and their male partners, especially in low-resource settings. These groups often face barriers such as stigma, fear, and limited access to traditional HIV-testing services. We reviewed qualitative and quantitative studies focusing on HIVST implementation in both public and private healthcare settings among pregnant and postpartum women and male partners in sub-Saharan Africa (SSA), analyzed uptake, male involvement, and barriers. Articles from Scopus, PubMed, and Google Scholar were included to examine public and private settings, distribution models, and psychosocial support. HIVST showed substantial success in increasing the testing rates. For example, maternal retesting during pregnancy has increased by 35% in Kenya due to the adoption of HIVST. The secondary distribution also drove male partner testing, with 90.8% of male partners accepting HIVST kits from their pregnant partners in South Africa and 75.4% participating in couple testing. Combining HIVST with clinical invitations increased both female and male testing 12-fold in other studies. Despite these successes, challenges persisted, with approximately 30% of women testing HIV-positive not returning to follow-up care. In addition, a few women reported adverse partner reactions, including intimate partner violence (IPV), after delivering HIVST kits. HIVST presents a critical opportunity to close gaps in HIV prevention between pregnant women and their male partners. Addressing barriers, such as stigma and enhancing male partner involvement, provides a pathway for more equitable testing practices. Scaling up successful community-based and secondary distribution models, alongside addressing challenges such as follow-up care and IPV concerns, is essential for reducing HIV transmission in SSA.

Training Social Network-Central Fishermen in Western Kenya to Distribute HIV Self-Test Kits and Health Facility Referral Vouchers

Low HIV testing among men, particularly highly mobile fishermen, is a persistent challenge. The Owete study (NCT#04772469) used social network-central men (Promoters) to promote testing and linkage to HIV services among social networks of fishermen in western Kenya. The Promoters and fishermen networks were randomised to intervention or control arms. We describe Owete’s interactive training approach and Promoters’ training experiences for implementation insights. The 146 Promoters trained (balanced across arms) were highly engaged, eager learners, and supportive of targeted health training sessions for men. Promoters felt the knowledge gained improved their understanding of health matters and elevated their social status. Promoters felt empowered knowing how to interpret self-testing results and how to address pre-exposure prophylaxis use questions and correct misconceptions. Offering capacity building for social network-central men to spearhead campaigns on health issues affecting fishermen can leverage established relationships and trust, expand knowledge, and help increase health-seeking practices among underserved, highly mobile men.

"There is no need to leave the beach to test": A qualitative study of HIV self-testing knowledge and acceptability of HIV self-test kit distribution among social networks of fishermen in western Kenya.

HIV self-testing (HIVST) can improve HIV testing uptake by offering convenience and privacy. Yet HIVST accessibility and uptake remain limited in Lake Victorias beach communities where HIVST holds promise to address many barriers highly mobile populations of men in fishing communities face. We assessed HIVST knowledge and acceptability among highly mobile fishermen, a high priority population for HIV prevention and treatment, participating in a social network-based study ("Owete"; NCT04772469) to promote HIV testing, prevention, and treatment in Kenya. Sixty-five in-depth baseline interviews (IDIs) and two focus group discussions (FGDs) were conducted at study baseline from December 2021 to June 2022 with fishermen, including 30 who were social network-central men recruited as HIVST "promoters" from three fishing communities along Lake Victoria, Kenya. Fishermen were purposively-sampled based on study arm, community and age (18-34 and 35+) for interviews exploring HIVST knowledge, perceived benefits, and concerns. IDIs and FGDs were audio-recorded, translated/transcribed into English and inductively-coded and analyzed by six researchers using a framework approach. Nearly all participants had heard about HIVST and expressed willingness to self-test. Almost half reported learning about HIVST for the first time through the Owete study. Perceived benefits of self-testing included privacy, convenience, and being able to learn one's status with the freedom to choose when and where to test, which minimized stigma and work interruptions. Few participants had used HIVST prior to joining Owete, all of whom reported ease of use. Potential barriers to HIVST included fear of HIV-seropositive results, feeling unsure about how to use HIVSTs, and fear of stigma if a HIVST was discovered. Nearly all Owete promoters indicated willingness to distribute HIVST to help their peers know their status. Promoters stressed the importance of approaching HIVST discussions strategically and thoughtfully to garner trust and engagement, and felt they needed training to answer HIVST questions. While few fishermen had ever used HIVST, this study found high awareness, positive perceptions, and substantial willingness to use and distribute HIVST to other men. The "promoter" model, with known peers engaged in disseminating HIVST information and test kits, shows promise for engaging men in testing.

Assessing whether providing regular, free HIV self-testing kits reduces the time to HIV diagnosis: an internet-based, randomised controlled trial in men who have sex with men.

The risk of onwards HIV transmission is strongly influenced by the interval between HIV infection and its diagnosis. The SELPHI trial examined whether this interval could be reduced by offering free HIV self-testing kits to men-who-have-sex with-men (MSM). Internet-based RCT of MSM aged ≥16 years, resident in England/Wales, recruited via sexual and social networking sites. The second-stage randomisation of SELPHI was open to participants who used an initial free HIV self-test kit, were HIV-seronegative, and reported recent condomless anal sex. They were randomised to receive a free HIV self-test kit every 3 months (repeat testing[RT] group) versus no such offer (nRT group). The primary outcome was time from randomisation to a confirmed HIV diagnosis, determined from linkage to national HIV surveillance databases. The key secondary outcome was the frequency of HIV testing regardless of test modality. 2308 eligible participants (1161 RT,1147 nRT) were randomised between April-2017 and June-2018, and followed for 15-27 months. The proportion of participants reporting an HIV test in the previous 3 months was much higher in the RT group (86%) than in the nRT group (39%). Overall, 16 (9 RT,7 nRT) confirmed HIV diagnoses were observed (0.35/100 person-years), with no difference in the time to a confirmed HIV diagnosis (hazard ratio=1.27 [95% CI 0.47-3.41], P=0.63). Providing regular free self-testing kits to sexually-active MSM was highly acceptable and markedly increased HIV testing. However, in this low incidence cohort it did not result in a demonstrably more rapid diagnosis of incident infections.

Prevalence, associated factors, barriers and facilitators for oral HIV self-testing among partners of pregnant women attending antenatal care clinics in Wakiso, Uganda

BackgroundOral HIV self-testing (HIVST) among men is relatively low and still inadequate in Sub-Saharan Africa. Delivering HIVST kits by pregnant women attending antenatal care to their partners is a promising strategy for increasing HIV testing among men. However, even amidst the HIV testing interventions, most men do not know their HIV status. This study, aimed to determine the proportion of partners who received and used oral HIVST kits delivered by pregnant women, associated factors, barriers, and facilitators for uptake.MethodsWe conducted an exploratory sequential mixed methods study among 380 sampled partners. Lists of partners from HIVST logbooks whose women picked an HIVST kit were obtained and systematic sampling was done to recruit participants. Fourteen (14) male partners were purposively selected for in-depth interviews to identify barriers and facilitators. We used modified poison regression to determine factors associated with oral HIVST. We used an inductive thematic analysis for qualitative analysis.ResultsOut of 380 participants, 260(68.4%) received an oral HIVST kit from their pregnant women, and 215(82.7%) used it for HIVST. Oral HIVST was associated with; Information Education and Communication like availability of HIVST guiding materials (aPR = 1.64, 95%CI: 1.48–1.82), being reached at home (aPR = 1.04, 95%CI 1.01–1.08), and being aware of the woman’s HIV status (aPR = 1.04, 95%CI 0.99–1.09). In-depth results identified barriers to uptake as, lack of trust in the HIVST kit results, fear of test outcome in the presence of their partner and inclination that the HIV status of their women is the same as theirs; Facilitators included convenience, ease of use, prior awareness of their HIV status, and fear of relationship consequences and breakup.ConclusionDelivery of oral HIVST kits to men through pregnant women reached a high number of men and achieved high uptake. Accessing information, education, communication and the kit’s convenience were major reasons for uptake among men who received the kit as; trust issues affected its use among partners. Scaling up the delivery of oral HIVST kits at all departments of hospitals through women seeking health services is paramount to support HIV screening among men to reach the UNAIDS 95 strategy.

Acceptability and feasibility of HIV self-testing distribution modes among key populations in Morocco.

HIV self-testing was introduced to enhance HIV testing uptake, especially among key populations. Despite the benefits, its use remains relatively low in the WHO Eastern Mediterranean Region. To assess the acceptability, usability and feasibility of HIV self-testing among key populations in Morocco. We assessed the usability and acceptability, as well as the feasibility of ordering online and picking up in pharmacies and of distribution by people living with HIV of an oral HIV self-testing kit among 3465 female sex workers, men having sex with men, and partners of newly diagnosed people living with HIV in Morocco. Data were collected using 4 questionnaires administered online anonymously and analysed using Stata version 14.0. A total of 3465 individuals received the HIV self-testing kits, 54.4% male, 43.7% female and 1.9% transgender. High acceptability rates of 90.2%, 86.2% and 80.4% were reported among the female sex workers, men having sex with men, and partners of newly diagnosed people living with HIV, respectively. HIV positivity rates were 1.2% among the female sex workers and men having sex with men, and 4.3% among partners of people living with HIV. Between 44.0% and 73.4% of the participants had never been tested for HIV. Our findings highlight the value of extending HIV self-testing services to key populations in Morocco and possibly other countries in the Middle East and North Africa.

A community-based study of intention to use HIV self-testing among young people in urban areas of southern Ethiopia

In sub-Saharan Africa, young people are at high risk of HIV infection, representing nearly 4 out of 5 new infections. HIV self-testing (HIVST), a new and proactive testing scheme that involves self-collection of a specimen and interpretation of results, is deemed potentially helpful for increasing testing amongst population groups like young people who do not frequently use routine testing services. This study assessed young people’s intention to use HIVST in urban areas of southern Ethiopia drawing on the Theory of Planned Behaviour. A community-based cross-sectional study was conducted with 634 participants aged 15–24 years from six town administrations of two zones in January to February 2023. The participation rate was 634/636 yielding 99.7%. The OraQuick HIVST kit was demonstrated to young people recruited in a door-to-door survey with a face-to-face interview using an electronic questionnaire in a mobile phone-based application. Intention to use HIVST was measured from a 6-point Likert scale with scores of agreements ranging from 1 to 6. Descriptive statistics and ordinal logistic regression analysis were done using STATA version 18. Most of the participants agreed that they would use HIVST if it was available (86.3% agreeing or strongly agreeing). Interestingly, young people who perceived themselves at some to high risk were 0.51 times less likely to be in the higher order of intention to use when HIVST is available to them than those who perceived themselves at no to low risk. Intention to use HIVST increased by a factor of 1.29, 1.84 and 2.35 for every one-unit increase on the mean favourable attitude, perceived behavioural control, and acceptability scores, respectively. The majority of young people intended to use HIVST. Young people’s perceived behavioural control, and acceptability of HIVST affected their intention to use. Intention and subsequent use of HIVST can be enhanced through an understanding of the role of risk perception and positive attitude, confidence to perform and acceptance of the test. Implementation studies are required to examine the actual uptake of HIVST among young people.

How can HIV self-testing facilitate increased access to HIV testing among multiply marginalised populations? Perspectives from GBMSM and trans women in England and Wales

Background HIV self-testing (HIVST) may facilitate marginalised populations’ uptake of HIV testing, but whether the extent of marginalisation challenges individual uptake of HIVST remains under-researched. We aim to explore the perspectives of multiply marginalised cis-gender gay, bisexual and other men who have sex with men (GBMSM) and trans women on whether HIVST might increase their uptake of HIV testing. Methods We reanalysed qualitative interview data from SELPHI (the UK’s largest HIVST randomised trial) collected between 2017 and 2020 from marginalised populations, defined as people self-identifying as non-heterosexual, transgender, non-White ethnicity and/or with low educational attainment. Thirty-eight interviews with multiply marginalised individuals were thematically examined using the framework method. We specifically focussed on kit usability (a function of the interaction between blood-based HIVST kits and users), perspectives on how HIVST can improve access to HIV testing and suggestions on need-based scale-up of HIVST. Results HIVST kits were considered usable and acceptable by multiply marginalised GBMSM and trans women. The majority of interviewees highlighted multi-levelled barriers to accessing HIV testing services due to structural and social marginalisation. Their multiply marginalised identities did not impede HIVST uptake but often form motivation to self-test. Three potential roles of HIVST in the HIV testing landscape were identified: (1) alternation of HIVST and facility-based testing, (2) integration of HIVST into sexual health services and (3) substituting facility-based testing with HIVST in the future. Perceived beneficiaries of HIVST included trans communities, individuals with undisclosed sexuality and people with physical disabilities. Discussion HIVST can facilitate marginalised populations’ access and uptake of HIV testing by alternating with, integrating into and substituting for facility-based services in the UK. Marginalised identities did not present challenges but rather opportunities for person-centred scale-up of HIVST. Future implementation programmes should ensure equitable access to HIVST among trans people, men unable to disclose their sexuality, and perhaps people with physical disabilities.

Integrated Online-to-Offline Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and a Multiphase Trial.

HIV continues to have a disproportionate impact on specific populations in Malaysia, particularly men who have sex with men (MSM). HIV self-testing (HIVST) is a strategy that has been shown to scale up HIV testing rates. However, it faces shortcomings because of concerns about self-efficacy, result interpretation, and lack of counseling and linkage to care. This underscores the need for an innovative approach that integrates HIVST with timely counseling, expert guidance, and referrals to enhance engagement in relevant HIV prevention or treatment. This study aims to describe the protocol used in developing and testing a web-based platform (ie, CINTAI) providing an HIVST kit and real-time e-counseling to support online-to-offline linkage to HIV care services for MSM in Malaysia. The methods are reported according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines. In phase I, we will adapt existing HIVST web-based platforms to create a new online-to-offline HIVST and counseling platform called "CINTAI" for Malaysian MSM. In phase II, we will use a type 1 hybrid implementation trial design to determine the feasibility, acceptability, and preliminary efficacy of "CINTAI" compared with treatment as usual among Malaysian MSM, with assessments conducted over 6 months. Multilevel implementation factors will also be collected to guide future adoption and scale-up. We will enroll 78 MSM in the pilot randomized controlled trial. Baseline characteristics will be tested for homogeneity between groups using appropriate statistical tests. A generalized linear mixed model with random subject effects will account for within-subject correlation. Treatment assignment, time, interaction, and confounders will be included. The proportion of MSM tested for HIV over 6 months and other outcomes (pre-exposure prophylaxis for HIV or antiretroviral therapy linkage, HIV risk behaviors, and chemsex harm reduction) will be compared using linear contrasts. We completed phase I of the proposed study in April 2024 and started phase II in May 2024, with 15 participants recruited (7 in the CINTAI and 8 in the treatment-as-usual groups). On the basis of a series of formative works completed during phase I, we developed a fully functional, web-based platform that provides a digital platform for MSM in Malaysia to order HIVST kits for free and to receive HIV counseling, followed by offline linkage to HIV prevention services (if HIV negative) or HIV treatment services (if HIV positive). Despite being at high risk for HIV transmission, MSM in Malaysia have alarmingly low testing and linkage to HIV care services, prompting the need for innovative approaches to support HIV prevention efforts. If found to be feasible and acceptable, CINTAI can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries. DERR1-10.2196/60962.

Development and feasibility of the peer and nurse-led HIV Self-Testing Education and Promotion (STEP) intervention among social networks of men in Dar es Salaam, Tanzania: application of the ADAPT-ITT model

BackgroundAccording to the 2016–2017 Tanzania HIV Impact Survey, only 45% of men living with HIV (MLWH) were aware of their HIV status. In an effort to increase HIV testing in Tanzania, including among men, the Government of Tanzania passed a law in December 2019 allowing HIV self-testing (HIVST) to be included in the national testing strategies. The objective of this paper is to describe the development and pilot feasibility assessment of the Self-Testing Education and Promotion (STEP) intervention, which includes male peer education and demand creation for HIVST, and nurse-led distribution of HIVST kits in a community setting.MethodsThe development and piloting processes were guided by the ADAPT-ITT model and informed by a national PEPFAR/USAID-funded HIV implementation science project called Sauti.The adapted STEP intervention included the following two components: 1) peer-based HIVST promotion; and 2) nurse-led HIVST distribution. For the feasibility assessment, 25 men were selected and trained as peer educators in 2019 to promote HIVST among their peers before recruiting 253 men who received instructions and an HIVST kit from a nurse at a community-based study tent site.ResultsOf the 236 participants who completed the 1-month follow-up survey, 98.3% reported using the kit. The majority (92.4%) of participants reported a negative HIVST result while 4.2% (n = 10) received a positive result. Most (70%, n = 7) of the participants with a positive result sought follow-up services at a healthcare facility while 40.3% (n = 95) of the participants with a negative self-test result visited the community-based project site. Most of the men (53%, n = 129) did not visit a healthcare facility or the study site.ConclusionThe findings demonstrate that the combined peer-based promotion and nurse-led distribution of HIVST intervention was acceptable and feasible, though seeking follow-up services at healthcare facilities remained low. Future research should evaluate the effectiveness of offering nurse-led community-based clinical follow-up services in addition to HIVST rather than referral to facilities.