HIV Prevention Modality Research Articles

Brief Report: Outcomes of Individuals Using HIV Postexposure Prophylaxis-In-Pocket ("PIP") for Low-Frequency, High-Risk Exposures in Toronto, Canada.

HIV postexposure prophylaxis-in-pocket ("PIP") is a self-initiated, event-driven HIV prevention modality for individuals with a low frequency of HIV exposures. A cohort of 111 patients using PIP as their primary HIV prevention modality was longitudinally evaluated for PIP self-initiation, HIV and sexual transmitted infections, and switching to other HIV prevention modalities between February 2016 and December 2022. A total of 111 patients had 178.7 cumulative patient-years of PIP use. PIP was self-initiated 69 times by 35 (31.5%) individuals, with 0 HIV seroconversions identified. Thirty four individuals (30.6%) transitioned from PIP to pre-exposure prophylaxis and 33 individuals (29.7%) switched from pre-exposure prophylaxis to PIP. PIP is a useful addition to other pharmacologic HIV prevention tools, and may help prevent infection in those with a lower frequency of unanticipated HIV exposures.

Reconciling intimacy and safety: a qualitative systematic review of HIV pre-exposure prophylaxis implementation among gay and bisexual men

This review synthesises qualitative research on pre-exposure prophylaxis (PrEP) uptake by sexual minority men to provide an overarching conceptualisation of the implementation processes involved. Twenty-four studies—comprising 734 participants from USA, UK, France, Canada, and Taiwan—were synthesised using thematic synthesis. The synthesis elucidates the dual significance of PrEP uptake: (1) risk management: reinforcing relational circumstances, and rebalancing safety and risk; and (2) sexual empowerment: reclaiming health and sexuality and refocusing on sexual fulfillment and intimacy. Overall, the findings show how gay and bisexual men use PrEP to reconcile their antagonistic desires for intimacy and safety by recalibrating protection and reimagining intimacy. This review conceptualises the essence of users’ experiences of PrEP implementation as reconciliation work—the labour and agency in making and remaking practices to manage discontinuities and incongruities—about the new HIV prevention modality. The concept of reconciliation work illustrates how using PrEP influences users’ practices, which in turn, shape the meanings of PrEP use within the community. This work engenders contingent transformations and outcomes beyond HIV protection, encompassing the broader aspects of health and sexuality. Findings support the adoption of more holistic and empowering approaches to sexual health promotion and intervention.

Point-of-Care Test for Assessing Tenofovir Adherence: Feasibility and Recommendations from Women in an Oral PrEP Program in Kenya and Their Healthcare Providers.

Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality when taken as recommended. Women in sub-Saharan Africa may have adherence challenges that remain undisclosed to providers. Real-time measures that identify non-adherence can allow for immediate exploration of adherence challenges, counseling and interventions. We conducted a formative qualitative study in Kenya to explore oral PrEP experiences and reactions to a point-of-care urine test (UT) identifying recent (past 4days) non-adherence to tenofovir-based PrEP among female PrEP users (25 in-depth interviews; 4 focus groups) and health care provider (10 key informant interviews). Findings indicate that use of the UT would be highly feasible in the context of regular PrEP care, largely acceptable to clients and providers, and could improve adherence. Clients emphasized the need for transparent client-centered strategies in delivering results. This formative study informs the development of tools to implement this point-of-care UT in future interventional studies and clinical settings.

CASH TRANSFERS AND CAREGIVERS: WORKING TOGETHER TO REDUCE VULNERABILITY AND HIV RISK AMONG ADOLESCENT GIRLS IN JOHANNESBURG, SOUTH AFRICA

In South Africa adolescent girls have the highest HIV incidence of any sex or age cohort. Scalable HIV-prevention interventions targeting this group are critical for epidemic control. Reaching 12.2 million children, the Child Support Grant mitigates the socio-structural drivers of HIV risk. This qualitative study of eight adolescents and their caregivers in Westbury, Johannesburg, explored how caregiving increases protective potential. ‘Caregiving’ enhanced the HIV risk-reduction benefits of ‘cash’ when characterised by substantial positive caregiver-adolescent involvement and adequate levels of control and consistency. Results underpin the value of social protection as an HIV-prevention modality and endorse investment in caregiver support programmes.

An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose).

IntroductionYoung women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female‐controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention.MethodsUChoose was an open‐label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV‐uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bi‐monthly injectable contraceptive, monthly vaginal Nuvaring® or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring® (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods.ResultsOf the 180 participants screened, 130 were enrolled and randomized to the Nuvaring® (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring® users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring®, adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring® (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill.ConclusionsAdherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long‐acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.

Efficacy of silk fibroin biomaterial vehicle for in vivo mucosal delivery of Griffithsin and protection against HIV and SHIV infection ex vivo.

IntroductionThe majority of new HIV infections occur through mucosal transmission. The availability of readily applicable and accessible platforms for anti‐retroviral (ARV) delivery is critical for the prevention of HIV acquisition through sexual transmission in both women and men. There is a compelling need for developing new topical delivery systems that have advantages over the pills, gels and rings, which currently fail to guarantee protection against mucosal viral transmission in vulnerable populations due to lack of user compliance. The silk fibroin (SF) platform offers another option that may be better suited to individual circumstances and preferences to increase efficacy through user compliance. The objective of this study was to test safety and efficacy of SF for anti‐HIV drug delivery to mucosal sites and for viral prevention.MethodsWe formulated a potent HIV inhibitor Griffithsin (Grft) in a mucoadhesive silk fibroin (SF) drug delivery platform and tested the application in a non‐human primate model in vivo and a pre‐clinical human cervical and colorectal tissue explant model. Both vaginal and rectal compartments were assessed in rhesus macaques (Mucaca mulatta) that received SF (n = 4), no SF (n = 7) and SF‐Grft (n = 11). In this study, we evaluated the composition of local microbiota, inflammatory cytokine production, histopathological changes in the vaginal and rectal compartments and mucosal protection after ex vivo SHIV challenge.ResultsEffective Grft release and retention in mucosal tissues from the SF‐Grft platform resulted in protection against HIV in human cervical and colorectal tissue as well as against SHIV challenge in both rhesus macaque vaginal and rectal tissues. Mucoadhesion of SF‐Grft inserts did not cause any inflammatory responses or changes in local microbiota.ConclusionsWe demonstrated that in vivo delivery of SF‐Grft in rhesus macaques fully protects against SHIV challenge ex vivo after two hours of application and is safe to use in both the vaginal and rectal compartments. Our study provides support for the development of silk fibroin as a highly promising, user‐friendly HIV prevention modality to address the global disparity in HIV infection.

Validation of the HIV Pre-exposure Prophylaxis Stigma Scale: Performance of Likert and Semantic Differential Scale Versions

Stigma regarding HIV pre-exposure prophylaxis (PrEP) is commonly implicated as a factor limiting the scale-up of this highly effective HIV prevention modality. To quantify and characterize PrEP stigma, we developed and validated a brief HIV PrEP Stigma Scale (HPSS) among a group of 279 men who have sex with men (MSM). Scale development was informed by a theoretical model to enhance content validity. We assessed two scale versions, Semantic Differential and Likert, randomizing the order in which scales were presented to participants. Both scales demonstrated high internal consistency. The Likert scale had substantially better construct validity and was selected as the preferred option. Scale scores demonstrated construct validity through association with constructs of interest: healthcare distrust, HIV knowledge, perceived proportion of friends/partners on PrEP, perceived community evaluation of PrEP, and perceived effectiveness of PrEP. The scale accounted for 25% of the total variance in reported willingness to be on PrEP, indicating the substantial role PrEP stigma may have on decisions to initiate PrEP. Given increased efforts to roll-out PrEP, having a valid tool to determine the level and types of PrEP stigma in individuals, groups, and communities can help direct implementation plans, identify goals for stigma reduction, and monitor progress over time.

HIV postexposure prophylaxis-in-pocket: long-term follow-up of individuals with low-frequency, high-risk HIV exposures.

HIV preexposure prophylaxis and postexposure prophylaxis are two major biomedical HIV prevention modalities. The utility of these prevention tools for individuals with infrequent high-risk HIV exposures remains uncertain. HIV postexposure prophylaxis-in-pocket ('PIP') may be an effective HIV prevention tool in such situations. Here, we present long-term follow-up of a cohort of patients initiated on PIP for HIV prevention. We retrospectively evaluated clinical characteristics of patients initiated on PIP as a primary HIV prevention tool between 1 January 2016 to 31 May 2019 at the Toronto General Hospital HIV Prevention Clinic and St. Michael's Hospital HIV Clinic, both in Toronto, Canada. Patients were referred for consideration of a biomedical HIV prevention modality. Individuals with a low frequency of high-risk exposures to HIV were initiated on PIP after counselling, and were followed at regular intervals. Demographic and clinical data was collected with a standardized form. In total, 79 patients were initiated on PIP as a primary HIV prevention modality and followed for a mean duration of 14.8 months combining for a total of 97.3 patient-years. Twenty-one (26.6%) patients used their PIP, and 32 courses of PIP were taken during the study period. Transitions between HIV prevention modalities included 13 (16.5%) patients who transitioned from PrEP to PIP, and 22 (27.8%) patients who transitioned from PIP to PrEP. No HIV seroconversions were detected during the course of this study. PIP is helpful HIV prevention modality for individuals with a low frequency of high-risk HIV exposures.

A Feasibility Literature Review, to Explore the Need to Undertake a Study, to Assess the Level of Knowledge and Awareness of HIV Pre-exposure Prophylaxis (PrEP) as an HIV Prevention Modality, Among Young Adults Attending Institutes of Higher Learning in Durban, Kwa -Zulu Natal, South Africa

HIV-AIDS is an alarming health concern both globally and locally which continues to increase, despite efforts to curb the epidemic. The rate of new infections is the greatest in the younger age group between 18-35 years of age with women being more infected than men1. In the absence of a cure for the disease, the mainstay of clinical management involves adherence to lifelong anti-retro viral (ARV) therapy4. Another integral component in trying to decrease new HIV infections is enhancing HIV-AIDS prevention modalities. These approaches have grown through the years and range from local to systemic forms either singly or in combination with other therapies4. An emerging potentially viable option is Pre-exposure prophylaxis (PrEP) (5). This form of therapy is the ingestion of a type of ARV on a daily basis by an HIV-Negative individual to remain HIV free. There are several clinical trials ongoing and past that have shown efficacy for use in adults and primarily in young adults. The rollout of PrEP as prevention modality globally has commenced and South Africa stands on the brink of roll out for high risk and young adults through the South African Department of Health ARV treatment programme. It is thus imperative that a study to explore the level of knowledge and awareness of HIV pre-exposure prophylaxis (PrEP) as an HIV prevention modality among young adults occurs in order to assess readiness for implementation in order to identify potential challenges with recommendations for smart practices.

1270. Population-Based Estimates of PrEP Access in Oregon, 2012–2016

BackgroundPrEP is an important HIV prevention modality. Population-based metrics of PrEP uptake and access are critical to the evaluation of public health efforts to increase PrEP use.MethodsUsing the Oregon All Payers All Claims administrative dataset, we determined the number of unique individuals at least 16 years of age starting PrEP, defined as at least one prescription of >30 days of Truvada, each year from 2012–2016. People with HIV or hepatitis B were excluded. We created two metrics of PrEP access in 2016: the number of individuals starting PrEP per 100K population and the number of individuals with a PrEP prescription in each of the four quarters of 2016 per 100K population (i.e., prevalent users). Using public health surveillance data, we created three metrics of PrEP need in 2016: the number of HIV diagnoses per 100K population; the number early syphilis and gonorrhea diagnoses per 100K population; and the number of acute or chronic hepatitis C diagnoses among patients aged 16–30 years per 100K population. We calculated six metrics of PrEP access-to-need by dividing each of the access measures by the need measures.ResultsThe number of individuals with a new PrEP prescription increased from 8 in 2012 to 571 in 2016. Most new PrEP users were men, aged 25–34 years, identified as white, lived in an urban area, had commercial insurance, and had an internal medicine PrEP prescriber. In 2016, there were 17.2 PrEP starts and 9.9 individuals with a PrEP prescription in all four quarters of 2016 per 100K population. There were 6.7 HIV cases, 136.0 early syphilis and gonorrhea cases, and 109.1 acute and chronic hepatitis C cases per 100K population. Per HIV diagnosis, there were 2.6 PrEP starts and 1.5 prevalent users. However, there were 0.13 PrEP starts and 0.07 prevalent users per early syphilis and gonorrhea diagnosis and 0.16 PrEP starts and 0.09 prevalent users per hepatitis C diagnosis. Women, people aged 16–24, people of color, and people in rural areas experienced lower PrEP access-to-need.ConclusionAccess metrics based on prevalent users (a measure of longer-term adherence to PrEP), STI diagnoses (a measure of HIV acquisition risk), and HCV diagnoses among those less than 30 years of age (a measure of need among people who inject drugs) may provide a more complete assessment of PrEP access-to-need than those based on PrEP starts and HIV diagnoses. Disclosures All authors: No reported disclosures.

Pre-Exposure Prophylaxis in Trans Populations: Providing Gender-Affirming Prevention for Trans People at High Risk of Acquiring HIV.

Transgender (trans) people, particularly trans women of color, face alarmingly high rates of HIV. HIV pre-exposure prophylaxis (PrEP) with daily coformulated emtricitabine and tenofovir disoproxil fumarate is a promising biomedical HIV prevention modality; however, it has not yet been shown to be efficacious in the transgender population due to data limitations. Initial data suggest that barriers exist to PrEP uptake in the trans community, including lack of access to healthcare and concerns about interactions with hormone therapy. This article discusses these factors and reviews considerations for enhancing PrEP uptake and adherence in trans people at risk for HIV.

Brief Report: HIV Postexposure Prophylaxis-in-Pocket ("PIP") for Individuals With Low-Frequency, High-Risk HIV Exposures.

On-demand preexposure prophylaxis may reduce one's risk of HIV acquisition; however, it is unclear if individuals with a very low frequency of HIV exposures are conferred adequate protection. We evaluated a novel approach dubbed HIV postexposure prophylaxis-in-pocket ("PIP"), for individuals with a low frequency of high-risk HIV exposures. Two HIV clinics in Toronto, Canada, managing HIV prevention cases. A retrospective evaluation of patients referred to HIV clinics for preexposure prophylaxis between January 1, 2013, and September 30, 2017, inclusive. After counseling and education, selected patients were initiated on PIP if they were having very infrequent HIV exposures. Thirty patients were prescribed PIP. Four patients (13.3%) used PIP during this study. There were no HIV seroconversions in 21.8 cumulative patient-years of PIP. PIP may be a useful HIV prevention modality for individuals with a very low frequency of HIV exposures.

PrEP and Our Youth: Implications in Law and Policy

2. Minor Consent Pursuant to Emancipation Exceptions A minor who has reached the age of majority is automatically considered emancipated, but those under the age of majority who achieve legal emancipation, either by statutory mandate or judicial decree, have a greatly expanded range of rights and responsibilities. (175) All states have laws pertaining to the emancipation of minors who have not yet reached the age of majority. Emancipation may be de jure or de facto. De jure emancipation, or emancipation by law, occurs through court intervention, where a minor petitions a court to grant him or her the rights and responsibilities of adulthood. De jure emancipation, while an important tool, is of minimal significance for operationalizing PrEP for at-risk minors. Concerns about cost, privacy, and delay inherent in court intervention would likely be prohibitive for the majority of at-risk youth. Thus, operationalizing PrEP for minors without parental consent will require reviewing more economically feasible, confidential, and efficient solutions. De facto emancipation, or emancipation by right, is enabled by state statute and occurs when a minor has achieved a certain status or has certain "individual or social circumstances." (176) In these limited circumstances, the law presumes that the minor has the capacity to understand the risks and benefits of adult activities, and the minor may consent to general medical care (177) without court intervention. Thus, a minor who becomes a member of the armed forces, (178) enters into a marriage or receives a divorce, (179) graduates from high school, (180) is pregnant, (181) lives independently from his or her parents and is financially self-sufficient, (182) or is homeless (183) may, by virtue of this status, consent to a broad range of medical interventions. (184) No state law permits minors to consent to PrEP therapy or any other pharmacological HIV prevention modality. (185) However, some de facto emancipation exceptions that permit minors to consent to general medical care coincide with the personal, family, or social circumstances of certain at-risk minors. At-risk minors who are unaccompanied, have no contact with or live independently of caregivers, refuse to seek parental consent, or could endure mental or physical abuse should the provider seek parental consent likely comprise a great deal of PrEP candidates. Thus, it is critical to consider how state law treats minors in these circumstances. If a state permits a minor to consent to his or her own general medical care in these situations, advocates are presented with an excellent opportunity to operationalize PrEP for broad spectrum of high-risk youth who would likely eschew preventive HIV care in the event that parental consent is required. By statute, more than half of United States jurisdictions (186) permit certain minors to consent to general medical care, which by implication could include PrEP or other pharmacological HIV prevention modalities. (187) These statutory exceptions to the general rule that minors may not consent to their own medical care may be divided into six types: (1) separation and financial independence exceptions; (2) maturity exceptions; (3) mid-adolescence exceptions; (4) medical necessity exceptions; (5) parental unavailability or non-engagement exceptions; and (6) homeless youth exceptions. (188) Within this framework, I discuss each, and potential implications for operationalizing PrEP for self- consenting minors. a. Separation and Financial Independence Exceptions At least fifteen jurisdictions have statutes specifying that qualifying minors living separate and apart from their parents or guardians and "managing their own financial affairs" may consent on their own behalf to general medical care. (189) Some statutes do not specify the length of separation and financial independence. (190) In these jurisdictions, the exception may apply not just to those minors with sufficient financial means to live independently, but also to minors who are homeless, unstably housed, runaways, castaways, or living on the street, as long as those minors do not currently live with their parents or guardians and are not reliant upon them for financial assistance. …

PrEP and Our Youth: Implications in Law and Policy

2. Minor Consent Pursuant to Emancipation Exceptions A minor who has reached the age of majority is automatically considered emancipated, but those under the age of majority who achieve legal emancipation, either by statutory mandate or judicial decree, have a greatly expanded range of rights and responsibilities. (175) All states have laws pertaining to the emancipation of minors who have not yet reached the age of majority. Emancipation may be de jure or de facto. De jure emancipation, or emancipation by law, occurs through court intervention, where a minor petitions a court to grant him or her the rights and responsibilities of adulthood. De jure emancipation, while an important tool, is of minimal significance for operationalizing PrEP for at-risk minors. Concerns about cost, privacy, and delay inherent in court intervention would likely be prohibitive for the majority of at-risk youth. Thus, operationalizing PrEP for minors without parental consent will require reviewing more economically feasible, confidential, and efficient solutions. De facto emancipation, or emancipation by right, is enabled by state statute and occurs when a minor has achieved a certain status or has certain individual or social (176) In these limited circumstances, the law presumes that the minor has the capacity to understand the risks and benefits of adult activities, and the minor may consent to general medical care (177) without court intervention. Thus, a minor who becomes a member of the armed forces, (178) enters into a marriage or receives a divorce, (179) graduates from high school, (180) is pregnant, (181) lives independently from his or her parents and is financially self-sufficient, (182) or is homeless (183) may, by virtue of this status, consent to a broad range of medical interventions. (184) No state law permits minors to consent to PrEP therapy or any other pharmacological HIV prevention modality. (185) However, some de facto emancipation exceptions that permit minors to consent to general medical care coincide with the personal, family, or social circumstances of certain at-risk minors. At-risk minors who are unaccompanied, have no contact with or live independently of caregivers, refuse to seek parental consent, or could endure mental or physical abuse should the provider seek parental consent likely comprise a great deal of PrEP candidates. Thus, it is critical to consider how state law treats minors in these circumstances. If a state permits a minor to consent to his or her own general medical care in these situations, advocates are presented with an excellent opportunity to operationalize PrEP for broad spectrum of high-risk youth who would likely eschew preventive HIV care in the event that parental consent is required. By statute, more than half of United States jurisdictions (186) permit certain minors to consent to general medical care, which by implication could include PrEP or other pharmacological HIV prevention modalities. (187) These statutory exceptions to the general rule that minors may not consent to their own medical care may be divided into six types: (1) separation and financial independence exceptions; (2) maturity exceptions; (3) mid-adolescence exceptions; (4) medical necessity exceptions; (5) parental unavailability or non-engagement exceptions; and (6) homeless youth exceptions. (188) Within this framework, I discuss each, and potential implications for operationalizing PrEP for self- consenting minors. a. Separation and Financial Independence Exceptions At least fifteen jurisdictions have statutes specifying that qualifying minors living separate and apart from their parents or guardians and managing their own financial affairs may consent on their own behalf to general medical care. (189) Some statutes do not specify the length of separation and financial independence. (190) In these jurisdictions, the exception may apply not just to those minors with sufficient financial means to live independently, but also to minors who are homeless, unstably housed, runaways, castaways, or living on the street, as long as those minors do not currently live with their parents or guardians and are not reliant upon them for financial assistance. …

Transitioning to HIV Pre-Exposure Prophylaxis (PrEP) from Non-Occupational Post-Exposure Prophylaxis (nPEP) in a Comprehensive HIV Prevention Clinic: A Prospective Cohort Study.

The uptake of pre-exposure prophylaxis (PrEP) for HIV prevention remains low. We hypothesized that a high proportion of patients presenting for HIV non-occupational post-exposure prophylaxis (nPEP) would be candidates for PrEP based on current CDC guidelines. Outcomes from a comprehensive HIV Prevention Clinic are described. We evaluated all patients who attended the HIV Prevention Clinic for nPEP between January 1, 2013 and September 30, 2014. Each patient was evaluated for PrEP candidacy based on current CDC-guidelines and subjectively based on physician opinion. Patients were then evaluated for initiation of PrEP if they met guideline suggestions. Demographic, social, and behavioral factors were then analyzed with logistic regression for associations with PrEP candidacy and initiation. 99 individuals who attended the nPEP clinic were evaluated for PrEP. The average age was 32 years (range, 18-62), 83 (84%) were male, of whom 46 (55%) men who had have sex with men (MSM). 31 (31%) met CDC guidelines for PrEP initiation, which had very good agreement with physician recommendation (kappa=0.88, 0.78-0.98). Factors associated with PrEP candidacy included sexual exposure to HIV, prior nPEP use, and lack of drug insurance (p<0.05 for all comparisons). Combining nPEP and PrEP services in a dedicated clinic can lead to identification of PrEP candidates and may facilitate PrEP uptake. Strategies to ensure equitable access of PrEP should be explored such that those without drug coverage may also benefit from this effective HIV prevention modality.

Injectable agents for pre-exposure prophylaxis: lessons learned from contraception to inform HIV prevention.

Long-acting injectable (LAI) forms of preexposure prophylaxis (PrEP) are in clinical trials, generating much hope for HIV prevention. But this is not the first time that an injectable form of preventive medication has emerged: the contraceptive agent depomedroxyprogesterone acetate (DMPA) has an important precedent. DMPA's long journey, its initial reception, and ongoing implementation challenges can help inform the field of HIV prevention as we plan for approval, acceptance, and scale-up of LAI-PrEP. DMPA faced a long regulatory journey in the USA, with a lag of 25 years from initial application (1967) to approval (1992). Acceptance after introduction was rapid, but challenges hampered scale-up. Specific lessons learned include that extensive acceptability work is needed in parallel to product development. Also, low continuation rates, challenges with timing of initiation, and difficulty ensuring access for the most vulnerable populations have limited DMPA's impact. A new subcutaneous formulation presents opportunities for administration outside of clinical settings and for self-administration. Those involved in LAI-PrEP development and those who plan to be involved in its future implementation must consider these lessons and possible solutions from DMPA to ensure a successful future for this new HIV prevention modality.

Is preexposure prophylaxis ready for prime time use in HIV prevention research?

Is preexposure prophylaxis ready for prime time use in HIV prevention research?