More than 1,400 researchers, policymakers and advocates gathered at the Madrid Marriott Auditorium Hotel in Madrid, Spain for HIV Research for Prevention (HIVR4P), the only global scientific meeting dedicated exclusively to biomedical HIV prevention. During the five day conference (October 21-25), HPTN members presented research from 18 abstracts – seven oral presentations and 11 poster presentations – covering HPTN 067, HPTN 069, HPTN 074, HPTN 075, HPTN 077, HPTN 078 and the antibody mediated prevention (AMP) studies HVTN 703/HPTN 081 and HVTN 704/HPTN 085. HPTN data was also featured in four satellite sessions and Raphael Landovitz, MD, MSc, HPTN 077 and HPTN 083 protocol chair, delivered a talk on PrEP during a plenary session.
The HPTN and the HIV Vaccine Trials Network (HVTN) jointly-hosted State of the Art of HIV bNAbs for Prevention of HIV Infection. The session covered current topics on the clinical development of broadly neutralizing antibodies for HIV prevention and included an update on the AMP (Antibody Mediated Prevention) studies HVTN 703/HPTN 081 and HVTN 704/HPTN 085. Myron Cohen, MD, HPTN co-principal investigator and Larry Corey, MD, HVTN principal investigator co-chaired the session.
Wafaa El-Sadr, MD, MPH, MPA, HPTN co-principal investigator, co-chaired Current State of Play: PrEP Implementation Update and Challenges. The session provided participants with an update on where we are with pre-exposure prophylaxis (PrEP), future products, current understanding of the different approaches to oral PrEP implementation in low and middle-income countries, challenges faced, and solutions found, in efforts to scaleup programs. Nelly Mugo, MBChB, MPH, a member of the HPTN Women at Risk Scientific Committee, discussed key issues and controversies regarding PrEP implementation for adolescent girls and young women. Myron Cohen shared insights regarding the efficacy of daily oral PrEP in women and Susan Buchbinder, MD, a member of the HPTN 083 study team and MSM Scientific Committee, talked about PrEP persistence challenges and opportunities.
Engagement of African MSM in HIV Prevention Research: Effective Recruitment and Retention addressed how African men who have sex with men (MSM) can be successfully engaged in planned biomedical HIV prevention trials, discuss various recruitment and retention strategies from Africa and develop best practices and tools to inform future research in Africa and other regions. Victor Akelo, a member of the HPTN 075 study team in Kenya discussed lessons learned from HPTN 075. Ken Mayer, MD, chair of the HPTN MSM Scientific Committee, co-chaired the session.
Raphael Landovitz, MD, MSc, HPTN 077 and HPTN 083 protocol chair, and Steven Shoptaw, PhD, HPTN Executive Committee member co-chaired It Only Hurts a Little: Long-Acting Injectables for HIV Prevention and Treatment. Beatriz Grinsztejn, MD, PhD, Nyradzo Mgodi, MBChB, MMed, Omar Sued, MD, PhD, and Ntando Yola, PgDPH, were part of two moderated panels discussing clinical, behavioral, policy and community considerations associated with the implementation of long-acting injectable antiretrovirals for prevention and treatment.
Kostyantyn Dumchev, MD, MPH, presented An Integrated Intervention to Increase ART and MAT Reduces Mortality Among PWID: Results from the HPTN 074 Randomized Trial. The study provides evidence that an integrated intervention targeting HIV-infected people who inject drugs (PWID) can substantially reduce all-cause mortality among PWID and their injection partners. The reduction among indexes can be attributed to enhanced antiretroviral therapy (ART) and medication assisted treatment (MAT) uptake; the mechanisms for reduction among partners will be a subject of additional analyses.
Jeremy Sugarman, MD, MPH, MA, presented Beneficial Impacts Related to Participating in an International HIV Prevention Trial Involving People Who Inject Drugs. In this trial, most participants in both study arms reported beneficial impacts, likely reflecting direct and indirect benefits of participation.
Theo Sandfort, PhD, presented HIV Incidence Among Men Who Have Sex with Men (MSM) and Transgender Women (TGW) in Sub-Saharan Africa: Findings from the Multi-Country HPTN 075 Cohort Study. MSM and TGW in sub-Saharan Africa are at alarming risk for HIV acquisition, substantially higher than the risk among other groups in the region, such as young women. The exceptionally high HIV incidence indicates an urgent need for increased access to HIV prevention interventions that consider individual, social and structural factors affecting sexual health in this vulnerable population.
Betsy Tolley, PhD, MPH, presented Acceptability of Long-Acting Injectable Cabotegravir (CAB LA) in HIV Uninfected Individuals: HPTN 077. Long-acting injectable pre-exposure prophylaxis acceptability in the study was high, especially in non-U.S. sites and among women where both the need for new HIV prevention methods is greatest and contraceptive injectable use is widespread.
Raphael Landovitz, MD, MSc, presented Tail-phase Safety, Tolerability and Pharmacokinetics of Long-acting Injectable Cabotegravir (CAB LA) in HIV-uninfected Individuals: HPTN 077 Final Results. Exposure to decreasing cabotegravir plasma concentrations following the last injection was well tolerated. The tail of CAB LA for females was significantly increased compared to males. In at-risk persons who discontinue CAB LA, the pharmacokinetics (PK) tail phase may represent a period of risk for selection of CAB-resistant virus should HIV infection occur. Data from ongoing Phase 3 studies will help evaluate this risk.
Kate Mitchell, PhD, presented Potential Impact of Increased ART and PrEP Coverage on the HIV Epidemic Among MSM in Atlanta: Mathematical Modelling for HPTN 078. A substantial increase in viral suppression is needed to halve HIV incidence among MSM in Atlanta, in the absence of PrEP expansion. Simultaneous expansion of both ART and PrEP provision is necessary to substantially reduce HIV incidence.
AMP Studies (HVTN 703/HPTN 081 and HVTN 704/HPTN 085)
Gail Broder, MS, presented Standardized Metrics Can Reveal Region-Specific Opportunities in Community Engagement to Aid Recruitment in HIV Prevention Trials. Standardized metrics aid meaningful comparisons of which community engagement methods best help trial enrollment. Internet strategies have better success in the Americas/Switzerland than African countries. The data suggested that sites must tailor community engagement and recruitment strategies to their local environment and must be supported with resources enabling use of a range of approaches.
Brett Hanscom, PhD, presented Adaptive Non-Inferiority Margins in HIV Prevention Trials. Adaptive margins can maintain desired operating characteristics in HIV prevention non-inferiority trials.
Bonnie Dye, MPH, presented Interviewer Adjustment of Smart Pillbox Monitoring Did Improve Accuracy in Measuring Oral PrEP Adherence in HPTN 067. Overall, weekly interviews did meaningfully alter electronic drug monitoring (EDM) PrEP adherence data in HPTN 067. In addition, weekly interviews can provide more complete dosing information when EDM data are missing (device malfunction, for example). Note: poster title and conclusion were updated based on further data analysis after HIVR4P submission deadline.
Sharon Mannheimer, MD, presented Challenges to Collecting PrEP Adherence Data in the New York City Site of the HPTN 067 Study. Adherence measurement presented unique challenges at the New York City site. Differences may reflect socioeconomic issues, disparities faced by these mainly black and Latino men who have sex with men, and different hairstyles. The data showed adherence measurement methods should be tailored to populations being assessed and vetted prior to implementation.
HPTN 069/ACTG 5305
Ken Mayer, MD, presented Sexual Risk and Study Drug Detection in MSM Participants in a Phase II Study of Maraviroc (MVC) +/- Tenofovir DF (TDF) or FTC versus TDF/FTC for PrEP. In a study in which all participants received at least one antiretroviral (ARV) for PrEP, participants who reported condomless anal sex (CAS) and/or advanced education had higher rates of ARV drug detection. Findings suggest CAS, education and PrEP adherence are related, thus engaging PrEP users in understanding their HIV risks may facilitate prevention effective PrEP use.
Yamikani Mbilizi, MBBS, presented Impact of Childhood Sexual Abuse Among Sub-Saharan African Men Who Have Sex with Men and Transgender Women in HPTN 075. Experiencing sexual abuse in childhood was associated with factors known to increase the risk of HIV infection, including condomless, transactional and forced sex. To promote sexual health among MSM and transgender women (TGW) in sub-Saharan Africa, it is critical to acknowledge the impact of childhood sexual abuse (CSA), promote prevention of CSA and counsel on ways to overcome these negative experiences.
erica hamilton, MPH, presented Stigma, Self-Esteem and Depressive Symptoms in HIV-Infected Men Who Have Sex with Men (MSM and Transgender Women (TGW) in Sub-Saharan Africa (HPTN 075). Results suggest that MSM and HIV stigma had a negative impact on self-esteem and depressive symptoms. Efforts to reduce HIV stigma among MSM and TGW in sub-Saharan Africa could have far-reaching benefits.
Theresa Gamble, PhD, presented Finding MSM who may be Potential Amplified HIV Transmitters: Results from HPTN 078. Both recruitment methods found a very high percentage of participants who were infected with HIV or syphilis, many of whom were co-infected with both. These data suggest the co-infected participants were having unprotected sex, with one in five having the potential to transmit both syphilis and HIV. These data highlight the need to screen for and treat syphilis in conjunction with HIV, as well as the potential to use syphilis screening to find MSM who are HIV-infected and virally unsuppressed.
Stefan Baral, MD, MPH, presented Differences by Wave of Respondent-driven Sampling Recruitment Among Gay Men and Other Men Who Have Sex with Men (MSM) in Four U.S. Cities: Results from HPTN 078. MSM enrolled in earlier waves included those more known to community partners of clinical research sites. While there are city-specific network dynamics, these data highlight MSM enrolled later were less likely to be engaged with the LGBT community, less likely to disclose sexual orientation and less likely to report health care coverage. Taken together, these results suggest deep-chain respondent driven sampling is an effective recruitment strategy to find and recruit MSM marginalized from health care and from community and family support networks.
Romain Silhol, PhD, presented Understanding HIV Transmission Dynamics and the Impact of Past HIV Interventions Among MSM in Baltimore: A Modelling Study for HPTN 078. Researchers estimated condoms and antiretroviral therapy have had a modest impact on the HIV epidemic among MSM in Baltimore to date. Interventions targeting undiagnosed MSM or diagnosed but not in care are needed since the majority of new HIV infections have been attributed to these groups.
AMP Studies (HVTN 703/HPTN 081 and HVTN 704/HPTN 085)
Philip Andrew, RN, presented Retention in the Ongoing AMP Trials of VRC01, a Broadly Neutralizing Antibody (bnAb) to Prevent HIV in Women, MSM & Transgender People. Retention in a global study of intravenous infusions for HIV prevention is achievable, even among participant subsets in whom retention has been challenging in other HIV prevention trials. Early community engagement, streamlined study visits, and dynamic infusion visit windows are some factors credited with AMP's retention success.
Srilatha Edupuganti, MD, MPH, presented Antibody Mediated Prevention: Proof-of-Concept, Randomized, Blinded, Placebo-Controlled Trials to Assess Safety and Efficacy of VRC01 to Prevent HIV-1. Despite early skepticism of operational futility, the AMP trials are safely enrolling and retaining at-risk participants in the Americas, Europe and sub-Saharan Africa.