Pre-exposure Prophylaxis Demonstration Project Research Articles

Sexual behaviour and incidence of sexually transmitted infections among men who have sex with men (MSM) using daily and event-driven pre-exposure prophylaxis (PrEP): Four-year follow-up of the Amsterdam PrEP (AMPrEP) demonstration project cohort.

An increasing number of countries are currently implementing or scaling-up HIV pre-exposure prophylaxis (PrEP) care. With the introduction of PrEP, there was apprehension that condom use would decline and sexually transmitted infections (STIs) would increase. To inform sexual health counselling and STI screening programmes, we aimed to study sexual behaviour and STI incidence among men who have sex with men (MSM) and transgender women who use long-term daily or event-driven PrEP. The Amsterdam PrEP demonstration project (AMPrEP) was a prospective, closed cohort study, providing oral daily PrEP and event-driven PrEP to MSM and transgender women from 2015 to 2020. Participants could choose their PrEP regimen and could switch at each three-monthly visit. STI testing occurred at and, upon request, in-between 3-monthly study visits. We assessed changes in numbers of sex partners and condomless anal sex (CAS) acts with casual partners over time using negative binomial regression, adjusted for age. We assessed HIV incidence and changes in incidence rates (IRs) of any STI (i.e., chlamydia, gonorrhoea, or infectious syphilis) and individual STIs over time using Poisson regression, adjusted for age and testing frequency. A total of 367 participants (365 MSM) commenced PrEP and were followed for a median 3.9 years (interquartile range [IQR] = 3.4-4.0). Median age was 40 years (IQR = 32-48), 315 participants (85.8%) self-declared ethnicity as white and 280 (76.3%) had a university or university of applied sciences degree. Overall median number of sex partners (past 3 months) was 13 (IQR = 6-26) and decreased per additional year on PrEP (adjusted rate ratio [aRR] = 0.86/year, 95% confidence interval [CI] = 0.83-0.88). Overall median number of CAS acts with casual partners (past 3 months) was 10 (IQR = 3-20.5) and also decreased (aRR = 0.92/year, 95% CI = 0.88-0.97). We diagnosed any STI in 1,092 consultations during 1,258 person years, resulting in an IR of 87/100 person years (95% CI = 82-92). IRs of any STI did not increase over time for daily PrEP or event-driven PrEP users. Two daily PrEP users, and no event-driven PrEP users, were diagnosed with HIV during their first year on PrEP. Study limitations include censoring follow-up due to COVID-19 measures and an underrepresentation of younger, non-white, practically educated, and transgender individuals. In this prospective cohort with a comparatively long follow-up period of 4 years, we observed very low HIV incidence and decreases in the numbers of casual sex partners and CAS acts over time. Although the STI incidence was high, it did not increase over time. The study was registered at the Netherlands Trial Register (NL5413) https://www.onderzoekmetmensen.nl/en/trial/22706.

Concordance between daily diary reported PrEP intake and intraerythrocytic tenofovir diphosphate (TFV-DP) in the Amsterdam PrEP demonstration project.

We assessed the association and concordance between self-reported oral preexposure prophylaxis (PrEP) intake in a diary app and intraerythrocytic drug metabolite concentrations. AMPrEP was a prospective demonstration study providing daily and event-driven PrEP to MSM in Amsterdam, the Netherlands (2015-2020). Participants could record their PrEP intake in a diary app. Dried blood spots (DBS) were taken at 6, 12, 24, and 48 months and analysed for tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentrations. We included TFV-DP measurements preceded by diary completion on at least 90% of days in the 6 weeks prior. We examined the association between self-reported PrEP intake (i.e. number of pills) and TFV-DP concentrations using tobit regression with a random intercept per participant. We also calculated concordance between categorized PrEP intake (i.e. <2, 2-3, 4-6 or 7 pills per week) and categorized TFV-DP concentrations (i.e. <350, 350-699,700-1249 or ≥1250 fmol/punch) using weighted Cohen's kappa. Last, we calculated concordance between self-reported recent PrEP intake (yes/no, in past 2 days) and quantifiability of FTC-TP (yes/no) using Cohen's kappa. Seven hundred and fifty-nine DBS measurements from 282 MSM were included. Self-reported PrEP intake was strongly and positively associated with TFV-DP concentration (β = 0.77, 95% CI = 0.70-0.84, P < 0.0001). Concordance between categorized PrEP intake and TFV-DP concentration was moderate (κ = 0.44, 95% CI = 0.39-0.50). Concordance between self-reported recent PrEP intake and FTC-TP quantifiability was perfect (κ = 0.83, 95% CI 0.76-0.90). Self-reported PrEP intake in a diary app is strongly correlated with actual use, and therefore reliable for comparing PrEP adherence between groups. Still, suboptimal criterion validity according to clinically relevant categories warrants caution when assessing 6-week reported adherence for individuals.

Evaluating the Screening and Enrollment of People at Risk of HIV in Mexico's Preexposure Prophylaxis Demonstration Project, 2018-2020.

Screening tools in which participants self-report sexual behaviors can identify people at risk of HIV acquisition for enrollment in preexposure prophylaxis (PrEP). We compared enrollment outcomes (ie, receiving PrEP vs being excluded by a counselor or declining PrEP) in Mexico's PrEP demonstration project and evaluated the validity of a 4-criteria PrEP eligibility tool in which participants self-reported risk behavior-having condomless anal sex, transactional sex, a partner living with HIV, or a sexually transmitted infection-as compared with PrEP eligibility assessed by a counselor. We recruited men who have sex with men and transwomen who were offered PrEP services in Mexico. We characterized participants according to enrollment outcome and identified underlying factors through logistic regression analyses. We calculated the sensitivity and specificity of the self-reported risk criteria, using the counselor's risk assessment as the point of reference. Of 2460 participants, 2323 (94%) had risk criteria of HIV acquisition according to the 4-criteria tool; 1701 (73%) received PrEP, 247 (11%) were excluded by a counselor, and 351 (15%) declined PrEP despite being considered eligible by the counselor. Participants who were excluded or who declined PrEP were less likely to report HIV risk behaviors than those who received PrEP, and participants who declined PrEP were more likely to be transwomen (vs men who have sex with men) and aged ≤25 years (vs >25 y). The 4-criteria risk tool had high sensitivity (98.6%) and low specificity (29.8%). The screening tool identified most participants at risk of HIV acquisition, but counselors' assessment helped refine the decision for enrollment in PrEP by excluding those with low risk. Public health strategies are needed to enhance enrollment in PrEP among some groups.

Family influences on oral PrEP use among adolescent girls and young women in Kenya and South Africa.

Effective use of oral HIV pre-exposure prophylaxis (PrEP) has been lower among African adolescent girls and young women (AGYW) than among older women, young men who have sex with men, and serodiscordant heterosexual couples in the region. Efforts to build PrEP support have centered around peers and male partners, but the family may also play an important role. This qualitative study aimed to describe family influence on PrEP use among AGYW in in three African cities. POWER (Prevention Options for Women Evaluation Research) was a PrEP demonstration project among 2550 AGYW (16-25 years old) in Johannesburg and Cape Town, South Africa and Kisumu, Kenya conducted from 2017 to 2020. In-depth interviews and focus group discussions were conducted with 136 AGYW participants to explore their PrEP views and experiences, including awareness and interest in PrEP; barriers and facilitators to uptake and use; the influence of family, peers, intimate partners, and community; and the key types of support for their PrEP use. Transcripts were coded and analysed thematically. The decision to initiate PrEP was associated with fear and anxiety linked to anticipated stigma from family members, and with family's lived HIV experience. Family disclosure, especially to mothers, was important to participants, as most lived with their families and considered it essential for them to obtain their mother's approval to use PrEP. Most family members, particularly mothers, provided instrumental, emotional, informational and appraisal support to participants using PrEP, including reminders, encouragement, and problem-solving. Participants reported that family members with insufficient information about PrEP safety and efficacy and who voiced concerns were a substantial barrier to their use. However, they often became supportive after receiving more PrEP information. Families, particularly mothers, can play an important role in supporting PrEP use. PrEP programmes should leverage family support to help with PrEP persistence by providing basic information to families about PrEP safety and efficacy. AGYW using PrEP should be encouraged to selectively disclose PrEP use to build support and counseled on how to disclose and address family concerns.

Online distribution of HIV self-testing kits to promote HIV testing among men who have sex with men discontinuing pre-exposure prophylaxis after demonstration project completion in China: a multicentre open-label randomized controlled trial

HIV self-testing (HIVST) offers potential solutions to challenges associated with site-based HIV testing (SBHT). However, the effectiveness of HIVST as an HIV prevention strategy for men who have sex with men (MSM) discontinuing pre-exposure prophylaxis (PrEP) after the completion of PrEP demonstration project has rarely been assessed. The China Real-world Study of Oral PrEP (CROPrEP) project was conducted in four cities in China. Participants were directed to community resources to continue their PrEP medication after the discontinuation of project-provided PrEP at the last CROPrEP visit. We conducted a multicentre open-label randomized controlled trial among MSM who had discontinued PrEP induced by the completion of CROPrEP. Eligible participants were randomly assigned to either the intervention group or the control group (1:1). Participants received regular health education and behavioural interventions throughout the trial. The intervention group was given a link to order free HIVST kits online, while the control group received information about free SBHT. Both groups completed internet-based follow-up surveys at three and six months. The primary outcome was the proportion of participants who underwent HIV testing during the six-month follow-up period. This trial was registered at chictr.org.cn (ChiCTR2000038416). Between November 2020 and January 2021, we recruited a total of 620 participants (300 in the intervention group and 320 in the control group). The follow-up completion rates were 99·0% and 95·0% in the intervention and control groups, respectively. At baseline, the median age of participants was 32 (interquartile range: 26-37), and 77·7% underwent HIV testing in the past three months. The proportion of participants who underwent HIV testing in the past three months was higher in the intervention group than in the control group at both the three-month (adjusted risk difference [RD]: 36·7, 95% confidence interval [CI]: 35·1-38·5, p<0·001) and six-month (RD: 26·7, 95% CI: 24·6-28·7 p<0·001) follow-up periods. Our study suggests that providing online distribution of HIVST kits for MSM with PrEP discontinuation induced by completion of the PrEP project effectively promoted HIV testing. This digital approach improves access to HIV testing for MSM and can be applicable to other settings where MSM turn to online public health services. The study was funded by the Fund of National Natural Science Foundation of China; the Mega-Projects of National Science Research for the 13th Five-Year Plan; and the Liaoning Revitalization Talents Program, China.

PrEPare_Morocco a successful community-based PrEP delivery demonstration program for men who have sex with men and female sex workers in Morocco

ABSTRACT Pre-exposure prophylaxis (PrEP) is an effective HIV prevention tool, recommended for persons at substantial risk for HIV, such as female sex workers (FSW) and men who have sex with men (MSM). We present Morocco's and the Middle East/North Africa's first PrEP demonstration project. Our pilot aimed to assess the feasibility and acceptability of a community-based PrEP program for FSW and MSM in Morocco's highest HIV prevalence cities: Agadir, Marrakech, and Casablanca. From May to December 2017, 373 eligible participants engaged in a 5–9 month program with daily oral TDF/FTC and clinic visits. Of these, 320 initiated PrEP, with 119 retained until the study's end. We report an 86% PrEP uptake, 37% overall retention, and 78% retention after 3 months. No seroconversions occurred during follow-up. These results underscore PrEP's need and acceptability among MSM and FSW and demonstrate the effectiveness of a community-based PrEP program in Morocco. These findings informed Morocco's current PrEP program and hold potential for the wider region with similar challenges.

“Entre Nosotras:” a qualitative study of a peer-led PrEP project for transgender latinas

BackgroundUptake of HIV pre-exposure prophylaxis (PrEP) remains low among transgender people as compared to other subgroups, despite high rates of HIV acquisition. In California, Latinx people comprise 40% of the population and Latina transgender women experience some of the highest burden of HIV of any subgroup, indicating a critical need for appropriate services. With funding from the California HIV/AIDS Research Programs, this academic-community partnership developed, implemented, and evaluated a PrEP project that co-located HIV services with gender affirming care in a Federally Qualified Heath Center (FQHC). Trans and Latinx staff led intervention adaptation and activities.MethodsThis paper engages qualitative methods to describe how a PrEP demonstration project- Triunfo- successfully engaged Spanish-speaking transgender Latinas in services. We conducted 13 in-depth interviews with project participants and five interviews with providers and clinic staff. Interviews were conducted in Spanish or English. We conducted six months of ethnographic observation of intervention activities and recorded field notes. We conducted thematic analysis.ResultsBeneficial elements of the intervention centered around three intertwined themes: creating trusted space, providing comprehensive patient navigation, and offering social support “entre nosotras” (“between us women/girls”). The combination of these factors contributed to the intervention’s success supporting participants to initiate and persist on PrEP, many of whom had previously never received healthcare. Participants shared past experiences with transphobia and concerns around discrimination in a healthcare setting. Developing trust proved foundational to making participants feel welcome and “en casa/ at home” in the healthcare setting, which began from the moment participants entered the clinic and continued throughout their interactions with staff and providers. A gender affirming, bilingual clinician and peer health educators (PHE) played a critical part in intervention development, participant recruitment, and patient navigation.ConclusionsOur research adds nuance to the existing literature on peer support services and navigation by profiling the multifaced roles that PHE served for participants. PHE proved instrumental to empowering participants to overcome structural and other barriers to healthcare, successfully engaging a group who previously avoided healthcare in clinical settings.

Demonstration project of oral TDF-containing PrEP, administered, once-daily orally to men having sex with men (MSM) and transgender women (TGW) in India: Study protocol.

India has successfully reduced Human Immuno-deficiency Virus (HIV) incidence, with a 66% decline since the year 2000 has been seen; however, control among Men having sex with Men (MSM) and transgender women (TGW) remains a critical challenge. Oral Pre-Exposure Prophylaxis (PrEP) may help close a critical HIV prevention gap for MSM and TGW in India; however, no studies to date have evaluated the feasibility of oral PrEP among MSM and TGW in India. The proposed study aims at understanding the implementation of the provision of daily oral-Tenofovir (TDF) containing PrEP among MSM and TGW through the clinic and community-based delivery models in Pune, Maharashtra, and Jalandhar, Punjab respectively in India. The study aims at estimating PrEP adherence, facilitators, and barriers to PrEP use, retention, acceptability, and willingness to pay for PrEP. After the screening, eligible participants (n = 600) will receive PrEP medicines and will be monitored quarterly for HIV, STIs, and renal and liver toxicity for 12 months as per the schedule of events. The primary outcomes of interest are PrEP acceptability, PrEP adherence, retention rate, adverse medical events, and sexual behavioural changes with PrEP use and breakthrough infections while on PrEP. The study will assess the feasibility of two service delivery models; however, the data from the two service delivery models will be analyzed independently and will not be compared for feasibility and other outcome indicators. The study has been initiated after obtaining appropriate regulatory approvals. PrEP is efficacious in preventing HIV among high-risk population however there are scarce data on providing PrEP to MSM and TGW. The study will provide critical evidence to programs and policymakers on the implementation of PrEP in a "real world" setting, among MSM and TGW in India including identifying populations that can benefit most from this additional HIV prevention intervention along with acceptable delivery strategies and means of support for adherence. Not applicable being a demonstration project. Efficacy is already proven.

Loss to Follow-Up from HIV Pre-Exposure Prophylaxis Care in Men Who Have Sex with Men in West Africa.

Loss to follow-up (LTFU) from HIV pre-exposure prophylaxis (PrEP) care compromises the goal of HIV elimination. We investigated the proportion of LTFU and associated risk factors among men who have sex with men (MSM) enrolled in a PrEP demonstration project in Burkina Faso, Côte d'Ivoire, Mali, and Togo. CohMSM-PrEP, a prospective cohort study, was conducted between November 2017 and June 2021 in community-based clinics. MSM aged 18 years or older at substantial risk of HIV infection received a comprehensive prevention package, including PrEP and peer education. LTFU was defined as not returning to the clinic for six months. Associated risk factors were investigated using a time-varying Cox's model. Of 647 participants followed up for a median time of 15 months, 372 were LTFU (57.5%). LTFU was associated with younger age (adjusted hazard ratio [95% Confidence Interval]; 1.50 [1.17-1.94]), unemployment (1.33 [1.03-1.71]), depression (1.63 [1.12-2.38]), and perceiving no HIV risk with stable male partners (1.61 [1.23-2.10]). Contacting peer educators outside of scheduled visits was protective (0.74 [0.56-0.97]). Our findings show that LTFU from PrEP care in West African MSM is a major challenge to achieving HIV elimination, but that the involvement of peer educators in PrEP delivery helps to limit LTFU by providing users with adequate support.

Human resource needs and costs for HIV pre-exposure prophylaxis provision in nurse-led primary care in Eswatini and opportunities for task sharing

BackgroundThe global expansion of HIV pre-exposure prophylaxis (PrEP) includes health systems that face a shortage of skilled health care workers (HCWs). We estimated the human resource needs and costs for providing PrEP in nurse-led primary care clinics in Eswatini. Furthermore, we assessed potential cost savings from task sharing between nurses and other HCW cadres.MethodsWe conducted a time-and-motion and costing study in a PrEP demonstration project between August 2017 and January 2019. A form for recording time and performed activities (“motion”) was filled by HCWs of six primary care clinics. To estimate the human resource needs for specific PrEP activities, we allocated recorded times to performed PrEP activities using linear regression with and without adjusting for a workflow interruption, that is, if a client was seen by different HCWs or by the same HCW at different times. We assessed a base case in which a nurse provides all PrEP activities and five task shifting scenarios, of which four include workflow interruptions due to task sharing between different HCW cadres.ResultsOn average, PrEP initiation required 29 min (95% CI 25–32) of HCW time and PrEP follow-up 16 min (95% CI 14–18). The HCW time cost $4.55 (uncertainty interval [UI] 1.52–9.69) for PrEP initiation and $2.54 (UI 1.07–4.64) for PrEP follow-up when all activities were performed by a nurse. Time costs were $2.30–4.25 (UI 0.62–9.19) for PrEP initiation and $1.06–2.60 (UI 0.30–5.44) for PrEP follow-up when nurses shared tasks with HCWs from lower cadres. Interruptions of the workflow added, on average, 3.4 min (95% CI 0.69–6.0) to the time HCWs needed for a given number of PrEP activities. The cost of an interrupted workflow was estimated at $0.048–0.87 (UI 0.0098–1.63) depending on whose time need increased.ConclusionsA global shortage of skilled HCWs could slow the expansion of PrEP. Task shifting to lower-cadre HCW in nurse-led PrEP provision can free up nurse time and reduce the cost of PrEP provision even if interruptions associated with task sharing increase the overall human resource need.

Out-of-pocket Expenses and Time Spent on Clinic Visits Among HIV Pre-exposure Prophylaxis Users and Other Clinic Attendees in Eswatini

User costs constitute a barrier to the uptake of HIV pre-exposure prophylaxis (PrEP), but their magnitude appears rarely assessed. In this prospective observational study, we assessed self-reported out-of-pocket expenses (OOPE) and time spent on clinic visits during a PrEP demonstration project in Eswatini. At six public primary care clinics, 240 PrEP users and other clinic attendees were interviewed after a clinic visit. Among the 79.2% of clinic attendees reporting any medical OOPE (e.g., expenses for consultations or drugs) and/or non-medical OOPE (e.g., expenses for transport, food, or phone use), the median total OOPE was $1.36 (IQR 0.91–1.96). Non-medical OOPE occurred mostly due to transport expenses. The median travel time for a clinic visit was 1.0 h (IQR 0.67–2.0). The median time spent in the clinic was 2.0 h (IQR 1.15–3.0). The median opportunity cost of a clinic visit was $7.54 (IQR 5.42–11) when valuing time spent on a clinic visit with Eswatini’s per-capita gross domestic product. Our findings can guide measures to reduce the user costs of PrEP in Eswatini and other contexts in which oral PrEP is provided through health care facilities.

Determinants of adherence to daily PrEP measured as intracellular tenofovir diphosphate concentrations over 24 months of follow-up among men who have sex with men

ObjectivesAdherence is key to the effectiveness of oral pre-exposure prophylaxis (PrEP) to prevent HIV. Therefore, we aimed to explore factors associated with adherence to daily PrEP (dPrEP).MethodsMen who have sex...

Gender-Based Violence and Post-traumatic Stress Disorder Symptoms Predict HIV PrEP Uptake and Persistence Failure Among Transgender and Non-binary Persons Participating in a PrEP Demonstration Project in Southern California.

Gender-based violence (GBV) against transgender and nonbinary (TGNB) persons is a pervasive public health issue. GBV has been linked to mental health problems such as depression and posttraumatic stress disorder (PTSD), as well has risk for HIV seroconversion and HIV treatment nonadherence. However, the impact of GBV on HIV pre-exposure prophylaxis (PrEP) use among TGNB persons has yet to be investigated. In the current study we assessed longitudinal PrEP persistence data from dried blood spots (DBS) collected from 172 racially and ethnically diverse TGNB participants during a 48-week PrEP demonstration project in Southern California from June 2017 to September 2020. Participants were categorized into three levels of PrEP uptake and persistence based on their PrEP levels at the start and end of the study: low-low, high-low, and high-high. Individual-, social-, and structural-level variables were then entered into multinomial logistic regression models to predict levels of PrEP uptake and persistence based on hypotheses informed by syndemic and minority stress theories. The models demonstrated that experience of GBV predicted significantly lower odds of PrEP uptake and persistence and greater PTSD symptoms predicted significantly greater odds of early PrEP discontinuation. Higher levels of coping skills, already being on PrEP at baseline, and being in a steady relationship were associated with greater odds of PrEP uptake and persistence. Implications forfuture GBV research, advocacy, interventions, and much needed structural changes focused on improving the health and safety of TGNB individuals are discussed.

The CHARISMA Randomized Controlled Trial: A Relationship-Focused Counseling Intervention Integrated Within Oral PrEP Delivery for HIV Prevention Among Women in Johannesburg, South Africa.

Consistent use of oral pre-exposure prophylaxis (PrEP) has been a challenge among women, particularly when in relationships with lack of partner support or intimate partner violence (IPV). We conducted a randomized controlled trial (RCT) of an empowerment counseling intervention called "CHARISMA" delivered to women within a PrEP demonstration project in Johannesburg, South Africa. The trial tested the effectiveness of CHARISMA to increase PrEP adherence; decrease social harms and IPV; and improve partnership dynamics (eg, communication, disclosure and support) compared with those who received the standard of care counselling support and referrals. Four hundred seven HIV-seronegative, nonpregnant women aged 18-45 years were enrolled for 6 months of PrEP use, with 203 randomized (1:1) to the intervention. All participants reporting IPV received counseling and referrals that followed the WHO five-step Listen, Inquire, Validate, Enhance Safety, and Support approach. This RCT did not identify statistically significant differences between study arms for PrEP adherence or relationship dynamics, with the exception of an increase in PrEP disclosure among intervention arm women. In our study, we cannot determine whether the lack of detectable findings may have been because of lack of intervention effect, strength of standard of care services, low risk in the study population, or other factors. Addressing IPV and relationship dynamics remain important factors influencing HIV risk, and addressing these within the context of PrEP delivery is an important synergistic opportunity. CHARISMA was highly acceptable to participants, and further adaptation and testing of the intervention to other populations and settings will augment the evidence base.

Facilitators of PrEP Persistence among Black and Latinx Transgender Women in a PrEP Demonstration Project in Southern California

Black and Latinx transgender women in the United States (U.S.) are at disproportionately high risk for HIV. Although HIV pre-exposure prophylaxis (PrEP) reduces the risk of HIV infection, uptake and persistence (i.e., ability to continue taking PrEP over time) can be a challenge for Black and Latinx transgender women due to myriad social and structural forces. In this qualitative study, we present unique data on the facilitators of PrEP persistence from Black and Latinx transgender women who initiated PrEP and exhibited varying levels of persistence during a demonstration project in Southern California. PrEP persistence was assessed by collecting quantitative intracellular tenofovir-diphosphate (TFV-DP) levels on dried blood spot (DBS) samples collected at weeks 12 and 48. Informed by the socioecological framework, we conducted and analyzed interviews using qualitative content analysis to determine themes on the facilitators of PrEP persistence. Individual-level facilitators included the use of reminders, having high individual-level HIV risk perception, feeling empowered to take PrEP, and reporting having improved peace of mind and mental health because of taking PrEP. Interpersonal/Community-level facilitators included feeling motivation to prevent HIV in the community, motivation to prevent HIV in the context of sex work, and having high community-level risk perception. Structural-level facilitators included having positive experiences in affirming healthcare settings and having PrEP visits combined with other gender-related healthcare visits. Interventions aiming to increase PrEP uptake and persistence among Black and Latinx transgender women in the U.S. should harness the multiple levels of support exhibited by those who were able to start and persist on PrEP in the face of the myriad social and structural barriers.

Awareness, Willingness and Use of HIV Pre-Exposure Prophylaxis Among Female Sex Workers Living in Dar-es-Salaam, Tanzania

Tanzania is in the final stages to roll out pre-exposure prophylaxis (PrEP) to Female Sex Workers (FSWs) so as to reduce new infections. PrEP demonstration projects support programming through gaining first experiences.We analyzed data from a cohort of 700 HIV negative FSWs in Dar-es-Salaam to determine proportions of FSWs who were aware, willing and used PrEP. We compared proportions at cohort enrolment and after 12 months. Logistic regression was used to determine factors associated with PrEP use. PrEP awareness increased from 67% to 97% after 12 months. Willingness was high at both time points (98% versus 96%). Only 8% (57/700) had used PrEP. Being married/cohabiting or separated/divorced/widowed and having sex with a HIV infected partner were independently associated with PrEP use. The PrEP program should focus on scaling up access as willingness to use PrEP is high.

A PrEP Demonstration Project Using eHealth and Community Outreach to Justice-Involved Cisgender Women and Their Risk Networks.

Women involved in criminal justice systems (WICJ) are a key population at risk for HIV, and pre-exposure prophylaxis (PrEP) is critical for HIV prevention. This project was designed to evaluate the feasibility and acceptability of delivering PrEP via eHealth to WICJ and members of their risk network (RN). We recruited HIV-negative cisgender WICJ index participants (n = 38) and risk network (RN) members (n = 67) using modified respondent-driven sampling. TDF/FTC was initiated for PrEP in participants meeting clinical criteria and dispensed through eHealth using a community-based, low barrier-to-care outreach model. Key steps in the PrEP care continuum were measured over 12 months. Enrolled participants (n = 105) had high current and lifetime justice-involvement and were predominantly cisgender women and non-Hispanic white with a mean age of 40.9y (SD 9.6). Despite most having primary care providers and medical insurance, PrEP awareness was low, and participants experienced high levels of medical, psychiatric, substance use, social, and economic need. Fifty-two participants (50%) were PrEP-eligible, of whom 24 (46%) initiated PrEP. TDF/FTC was safe and well-tolerated throughout follow-up and 13 individuals chose to remain on PrEP following study conclusion. In this novel PrEP demonstration project for WICJ and RN members, despite high medical, psychiatric, and social comorbidity, PrEP was positively received and effectively delivered using a community outreach model via eHealth.Registered on clinicaltrials.gov under trial registration number NCT03293290.

Parallel reductions in anxiety and HIV-related worry among pre-exposure prophylaxis (PrEP) users over time.

The threat of HIV has been proposed as a major contributing factor to the disproportionately higher rates of anxiety among gay and bisexual men compared to their heterosexual counterparts. The current study examined 12-month trajectories of anxiety symptoms and concomitant HIV-related worry among a cohort of preexposure prophylaxis (PrEP) users, compared to a comparison cohort who were not taking PrEP. SPARK was a community-based PrEP demonstration project conducted between February 2014 and May 2017. Self-report anxiety and worry data were collected from PrEP patients (n = 300) quarterly, and from non-PrEP patients (n = 131) at baseline, 3, and 12 months. We ran a series of unconditional latent growth curve models (LGCMs) to examine changes in anxiety and HIV worry over the 12-month study period, followed by parallel process LGCMs to examine the association between both intercepts and growth factors, adjusting for demographic factors. In a parallel process model, both an association between baseline levels of HIV worry and anxiety decreases in both variables over time among PrEP users but not among non-PrEP users. Additionally, a multigroup analysis was conducted, restricting both groups to 3 time points, and forcing a comparison of slopes between the 2 groups. This analysis revealed that there was no difference in the anxiety slopes between the 2 cohorts. However, the HIV worry slope remained significantly different among the PrEP cohort compared to the non-PrEP cohort. These data provide some of the first quantitative evidence for the potential of PrEP to reduce both HIV worry and anxiety symptoms. Emphasizing positive mental health "side effects" of PrEP may be a strategy for engaging priority populations in biomedical HIV prevention. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Implementation of Client-Centered Care Coordination for HIV Prevention with Black Men Who Have Sex with Men: Activities, Personnel Costs, and Outcomes—HPTN 073

BackgroundBlack men who have sex with men (MSM) experience disproportionate rates of HIV infection in the USA, despite being no more likely to engage in sexual risk behaviors than other MSM racial/ethnic groups. HIV pre-exposure prophylaxis (PrEP) has been shown to reduce risk of HIV acquisition; however, rates of PrEP use among Black MSM remain low. Clinical, psychosocial, and structural factors have been shown to impact PrEP use and adherence among Black MSM. Care coordination of HIV prevention services has the potential to improve PrEP use and adherence for Black MSM, as it has been shown to improve HIV-related care outcomes among people living with HIV.MethodsClient-centered care coordination (C4) is a multi-level intervention designed to address clinical, psychosocial, and structural barriers to HIV prevention services for Black MSM within HPTN 073, a PrEP demonstration project among Black MSM in three cities in the USA. The current study examined the implementation process of C4, specifically investigating the activities, cost, time, and outcomes associated with the C4 intervention.ResultsOn average, participants engaged in five care coordination encounters. The vast majority of care coordination activities were conducted by counselors, averaging 30 min per encounter. The cost of care coordination was relatively low with a mean cost of $8.70 per client encounter.ConclusionAlthough client-centered care coordination was initially implemented in well-resourced communities with robust HIV research and service infrastructure, our findings suggest that C4 can be successfully implemented in resource constrained communities.

866. Adherence to F/TDF for PrEP in Dried Blood Spots and HIV Infection Rates: A Pooled Analysis of Global PrEP Studies

BackgroundThe use of daily F/TDF for HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV acquisition. Dried blood spot (DBS) tenofovir-diphosphate (TFV-DP) levels reflect TDF use over the past 6-8 weeks, providing an objective measure of adherence in people taking PrEP.MethodsIn a pooled analysis of 19 PrEP demonstration projects and clinical studies, 6,613 participants had at least one TFV-DP measurement in DBS and followed for at least 48 weeks and up to 96 weeks. We used a piecewise linear mixed-effects model to plot the least-square means with corresponding 95% confidence intervals (CI) of TFV-DP for adherence over time, and Poisson regressions to calculate HIV incidence rates (IR) by level of weighted average of TFV-DP.ResultsOf 6,613 participants, median age was 30 years (interquartile range 24−38), 5,449 (82%) were cisgender men, 806 (12%) were cisgender women, and 349 (5%) were transgender (316 transgender women, 2 transgender men, 31 unspecified). Adherence based on TFV-DP in DBS was consistently higher among participants who did not acquire HIV compared to those who did (Figure). Among all participants, 21%, 14%, 36%, and 29% has DBS consistent with taking < 2, 2−3, 4−6, and ≥7 tablets of F/TDF PrEP per week (Table). Sixty-nine participants acquired HIV, with a median PrEP exposure of 0.82 years and an overall HIV IR (95% CI) of 1.16 (0.92, 1.47) per 100 person years. There was a strong association between adherence and HIV incidence [among individuals who took < 2, 2−3, 4−6, and ≥7 tablets/week, the HIV IRs (95% CI) were 5.20 (4.03, 6.71), 0.38 (0.12, 1.18), 0.28 (0.12, 0.61), and 0.06 (0.01, 0.39), respectively. Overall IR (95% CI) of HIV infection among cisgender men was 1.25 (0.98, 1.60) per 100 patient-years. Four cisgender women and 2 transgender participants acquired HIV, corresponding to IRs (95% CI) of 0.71 (0.27, 1.90) and 0.63 (0.16, 2.53).Adherence by TFV-DP in DBS for F/TDF users who acquired HIV compared to those who did not. Note: ‘x’ on the Figure represents visit week when a new HIV infection was detected.HIV incidence rates (95% confidence intervals) by adherence to PrEP measured by level of TFV-DP in DBS up to 96 weeks after PrEP Initiation ConclusionThis diverse, multi-national pooled analysis of F/TDF PrEP use provides the largest assessment to date of the adherence-HIV incidence relationship in people taking F/TDF for PrEP. The results suggest a high background HIV incidence in the pooled cohort and high efficacy in those adherent to PrEP. These findings support ongoing efforts to increase PrEP use among people who would benefit.Disclosures Albert Liu, MD, MPH, Gilead Sciences (Individual(s) Involved: Self): Gilead has donated study drug for studies I have led., Grant/Research Support, Other Financial or Material Support, Research Grant or Support; IAS-USA (Individual(s) Involved: Self): Honorarium for manuscript writing, Other Financial or Material Support; Viiv Healthcare (Individual(s) Involved: Self): Grant/Research Support, Research Grant or Support Raphael J. Landovitz, MD, MSc, Gilead Sciences (Individual(s) Involved: Self): Consultant; Janssen (Individual(s) Involved: Self): Consultant; Merck Inc (Individual(s) Involved: Self): Consultant; Roche (Individual(s) Involved: Self): Consultant Jared Baeten, MD, PHD, Gilead Sciences Inc. (Employee, Shareholder) David Magnuson, PharmD, Gilead Sciences Inc (Employee, Shareholder) Moupali Das, MD, Gilead Sciences Inc. (Employee, Shareholder) Christoph C. Carter, MD, Gilead Sciences Inc. (Employee, Shareholder) Li Tao, MD, PhD, Gilead Sciences Inc (Employee, Shareholder)