Acceptability of a rectal microbicide douche for HIV prevention: a mixed-methods analysis of a first-in-human formulation pilot study.

OBJECTIVES: DREAM-01 was an open label, dose-escalation and variable osmolarity study to identify a tenofovir HIV-prevention douche/enema that could achieve protective colon tissue cell concentrations and high acceptability. To assess impact on sexual enjoyment, iso-osmolar and hypo-osmolar placebo douches were provided for at-home use before receptive anal sex (RAS). METHODS: Eighteen HIV-uninfected men who have RAS were administered three tenofovir douches at the research clinic: Product A, an iso-osmolar dose; Product B, an iso-osmolar escalation dose; and Product C, a hypo-osmolar escalation dose. Following Products A and C, participants were given a saline douche of matching osmolarity to use at home before RAS. Participants reported acceptability via a computer-assisted self-interview and in-depth interview in this mixed-methods study. RESULTS: All three products were rated acceptable by 17 (95%) of the participants. A majority (94%) would be likely or very likely to use any of the three products before RAS. Of those who used the saline douches before RAS and then rated their sexual enjoyment, most reported that their sexual enjoyment was not affected. Interview data revealed that participants found the product easy to incorporate into their regular routine, but would prefer to use more liquid for cleansing. CONCLUSIONS: These findings indicate that the hypo-osmolar Product C, which also provides the most rapid delivery of tenofovir for HIV prevention, is acceptable for future safety trials and that our sample reports high likelihood of using a rectal microbicide douche for HIV prevention. Our findings support continued pursuit of a tenofovir rectal microbicide douche. TRIAL REGISTRATION NUMBER: NCT02750540.

Peer-to-Peer Chain Recruitment for Enrolling Young South African Women into an HIV Pre-exposure Prophylaxis (PrEP) Intervention Study: How Did It Perform?

Peer-to-peer chain recruitment has been used for descriptive studies, but few intervention studies have employed it. We used this method to enroll sexually active women ages 18 to 25 into an online Pre-Exposure Prophylaxis (PrEP) information and motivation intervention pilot in eThekwini (Durban), South Africa. Seeds (N = 16) were recruited by study staff and randomized to Masibambane, Ladies Chat, a Gender-Enhanced group-based WhatsApp Workshop (GE), or Individual-Access (IA), a control condition that provided participants with online information/motivation materials only. Each seed could recruit up to three women to participate in the same study condition, with an incentive for each enrolled woman; participants in subsequent waves could choose to recruit or not. We evaluated if peer-to-peer recruitment was self-sustaining and resulted in enrolling women who, in subsequent waves, had less contact with the health care system and less knowledge about PrEP than the initial seeds. Over three recruitment waves beyond the seeds, 84 women were recruited. Almost 90% of women became recruiters, with each recruiting on average 1.90 women and 1.26 eligible enrolled women. The approach was successful at reaching women with less education but not women with less health system contact and PrEP knowledge across waves. IA participants had a slightly higher, though non-significantly different, percentage of individuals who became Peer Health Advocates (PHAs) than GE participants and, on average, they recruited slightly more women who enrolled. Our findings demonstrated that peer-to-peer recruitment is a feasible and self-sustaining way to recruit SA young women into a PrEP intervention study.

Information, Motivation and Behavioral Skills as Mediators Between Sexual Minority Stigma and Condomless anal Sex Among Black South African Men Who have Sex with Men.

We assessed pathways between sexual minority stigma and condomless anal intercourse (CAI) among two samples of Black South African men who have sex with other men (MSM). Two cross-sectional surveys were conducted in Tshwane, South Africa; one among 199 Black MSM and another among 480 Black MSM. Men reported on external and internalized experiences of sexual minority stigma, mental health, alcohol use, information-motivation-behavioral skills (IMB) model constructs, and CAI. Structural equation modeling was used to test whether external and internalized stigma were directly and indirectly associated with CAI. In both studies, external stigma and internalized stigma were associated with CAI through IMB model constructs. These results suggest a pathway through which stigma contributes to HIV risk. For HIV prevention efforts to be effective, strengthening safer sex motivation and thus decreasing sexual risk behavior likely requires reducing sexual minority stigma that MSM experience and internalize.

Condomless Sex Among HIV-affected AYA in an Era of Undetectable = Untransmittable and Pre-exposure Prophylaxis.

Given poor adherence to treatment and prevention techniques, condomless sex jeopardizes adolescents and young adults (AYA) with perinatally-acquired HIV-infection (PHIV) or perinatal HIV-exposure who are uninfected (PHEU). We examined condomless sex and its association with PHIV-status, psychiatric disorder, and sociodemographics. Data come from a US-based study of primarily Black and Latinx AYAPHIV and AYAPHEU (N = 340). Linear regression models examined condomless sex longitudinally by PHIV-status, psychiatric trajectories, and sociodemographics. Rates of viremia (AYAPHIV) and PrEP use (AYAPHEU) were assessed. 56% of participants reported recent condomless sex, with higher prevalence among: AYAPHEU vs. AYAPHIV (24% vs. 19%, p = 0.017); Latinx vs. non-Latinx AYA (25% vs. 17%, p = 0.014); and AYA with increasing psychiatric comorbidity (44%) and consistent anxiety (23%) vs. low-level disorder (17%; p < 0.05). AYAPHIV had high rates of unsuppressed viral load and AYAPHEU limited PrEP use. Preventing condomless sex is challenging within AYAPHIV and AYAPHEU. Developing accessible combination HIV/mental health interventions is much-needed.

Acceptability and Feasibility of Providing Adherence Feedback Based on Tenofovir Diphosphate in Dried Blood Spots: Results from a Pilot Study Among Patients and Providers in Cape Town, South Africa.

Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) predict viral breakthrough, but their use remains understudied in real-world clinic settings. This pilot study examined acceptability, feasibility, and initial adherence outcomes of providing adherence feedback using TFV-DP concentrations on patient- and provider-levels in Cape Town, South Africa. We enrolled 60 persons with HIV (PWH) receiving tenofovir-containing ART attending a primary health clinic. They were randomized 1:1 to an intervention receiving TFV-DP concentration feedback by research staff vs. no feedback at monthly visits for 4 months. Acceptability among medical providers and level of clinical follow-up of TFV-DP results was examined. Patient acceptability was assessed descriptively. Mean electronic adherence (EA), as measured by WisePill device, and TFV-DP in DBS were compared between the two arms. All participants in the intervention group (100%) reported finding TFV-DP feedback helpful and 86% reported changing adherence behaviors. Medical providers indicated high acceptability of incorporating TFV-DP concentration feedback into the clinic, yet among 29 results < 1000 fmol/punch, only 2 were reviewed with no follow-up actions performed. In the intervention arm, mean TFV-DP concentrations were significantly higher (t = 2.5, p < .01) during follow-up and EA in upper quartile (96-100%) was greater compared to controls (x2 = 7.8, p ≤ .05). This study found high acceptability among patients for receiving adherence feedback based on TFV-DP concentrations. TFV-DP and EA data demonstrated greater adherence in the intervention group. Providers indicated high acceptability of incorporating TFV-DP feedback into the clinic, but few providers reviewed results, which could impact clinic-level feasibility.

Hope for the future protects against suicidal ideation among adolescents and young adults affected by perinatal HIV.

Hope for the future has been found protective against suicidal ideation (SI) in adolescents and young adults (AYA) yet has not been examined in AYA with perinatal HIV-infection (PHIV) or AYA who were perinatally HIV-exposed but uninfected (PHEU), who are at higher risk for SI than general populations. Using data from a New York City-based longitudinal study of AYAPHIV and AYAPHEU enrolled when 9-16 years old, we examined associations between hope for the future, psychiatric disorders, and SI over time using validated measures. Generalized estimating equations were used to estimate differences in mean hope for the future scores by PHIV-status and to estimate adjusted odds ratios for associations between hope for the future and SI. AYA reported high hope for the future scores and low SI across visits, irrespective of PHIV-status. Higher hope for the future scores were associated with lower odds of SI (AOR = 0.48, 95% CI: 0.23, 0.996). Mood disorder was associated with increased odds of SI (AOR = 13.57, 95% CI: 5.11, 36.05) in a model including age, sex, follow-up, PHIV-status, mood disorder, and hope for the future. Understanding how hope can be cultivated and how it protects against SI can help to inform preventive interventions for HIV-affected AYA.

Transgender Women's Experiences Using SMARTtest, a Smartphone Application to Facilitate Self- and Partner-HIV/Syphilis Testing Using the INSTI Multiplex.

We present experiences of transgender women (TW) who have sex with men with SMARTtest, a smartphone app to accompany the INSTI Multiplex®, a one-minute, dual blood-based HIV/syphilis rapid test. TW participants (N = 11) received 10 INSTI Multiplex® tests to take home for self- and/or partner-testing and installed the SMARTtest app on their phones. The SMARTtest app aimed to support INSTI Multiplex users in correctly performing the test, interpreting the results, and connecting with care following a positive HIV or syphilis screening. After 3 months, users completed in-depth interviews on their experiences. A total of 9 TW used SMARTtest with partners. App feedback was positive, but refining is necessary. Specifically, TW reported that SMARTtest is easy to use and convenient; instructions on how to use the INSTI Multiplex presented on the app were helpful to complete procedures correctly; the most frequently used feature on SMARTtest was the information on clinics that offered confirmatory testing; and participants and their partners were not concerned about app privacy but reported that this could change if INSTI Multiplex detected an HIV-positive result. Further, participants provided recommendations on how to improve SMARTtest, and changes were mostly related to features, content, functionality, navigation, and overall "look" of the app. SMARTtest is promising to facilitate INSTI Multiplex® use in TW. User feedback should be integrated in future versions.

Infrequent STI Testing in New York City Among High Risk Sexual and Gender Minority Individuals Interested In Self- and Partner-Testing.

Testing for sexually transmitted infections (STIs) remains low among sexual and gender minority populations. We assessed STI testing history using a retrospective survey among 129 HIV-negative cisgender men who have sex with men (cMSM) and transgender women who have sex with men (tWSM) who were at high risk for STI acquisition. All participants were enrolled in a parent study on self- and partner-testing for HIV and syphilis, and reported condomless anal intercourse with multiple partners during the prior 3 months. We additionally used bivariate tests to evaluate participants' STI testing by their history of using pre-exposure prophylaxis (PrEP). One-in-seven respondents (n = 18) reported having never tested for an STI, one-quarter (n = 33) had not tested in the past year, and two-thirds (n = 83) had never used PrEP. PrEP-naïve respondents were less likely to report recent STI testing (47% vs. 85%). "Routine doctor's visit" was the most prevalent reason for testing, but was less common among PrEP-naïve respondents (83% vs. 100%). Testing was remarkably low given the sample's high risk of HIV and STI infection. Findings suggest that STI testing is more frequent among those who have ever used PrEP, but the risk of selection bias warrants evaluation in a larger probability sample.

Experiences of Transgender Women Who Used a Dual HIV/Syphilis Rapid Self-test to Screen Themselves and Potential Sexual Partners (the SMARTtest Study).

HIV/syphilis self- and partner-testing may be especially appropriate for transgender women, since they shoulder a disproportionate burden of HIV, other STIs (e.g., syphilis), and report high levels of medical mistrust. The SMARTest study enrolled N = 50 sexual and gender minority individuals. The present analysis aims to understand the experiences (via in-depth interviews) of a subset of n = 11 transgender women who used INSTI Multiplex®, a combination HIV/syphilis rapid self-test, on themselves and potential sex partners. Participants reported that many partners were willing to test, and reported no testing-related violence. Most participants completed tests successfully, though gaining comfort with blood collection took time. There were no HIV-positive tests in this study; one participant and two partners reported a positive syphilis screening. All sought care. Our sample was small and results should be interpreted with caution, but indicate potential future directions for conducting research on self- and partner-testing among transgender women.

Acceptability and Use of a Dual HIV/Syphilis Rapid Test and Accompanying Smartphone App to Facilitate Self- and Partner-Testing Among Cisgender Men and Transgender Women Who Have Sex with Men.

At home self- and partner-testing may reduce HIV and syphilis transmission by detecting undiagnosed infections. Forty-eight cisgender men and transgender women who men who have sex with men were given ten INSTI Multiplex kits and downloaded the SMARTtest app to facilitate self- and partner testing over the next three months. Thirty-seven (77%) participants self-tested using the INSTI (mean = 3.7 times, SD = 3.9); 26 (54%) tested partners (mean = 1.6 times, SD = 2.2). Participants liked the test for its ease of use, quick results, and dual HIV/syphilis testing but its blood-based nature hindered use with partners. Participants with reactive syphilis results always attributed them to a past infection and these results presented a challenge to testing with partners and the ability to accurately assess risk of infection. Most participants stated they would use the INSTI for self-testing (100%) and for partner-testing (89%). Acceptability of the SMARTtest app was high for functionality (M = 4.16 of max 5, SD = 0.85) and helpfulness (M = 6.12 of max 7, SD = 1.09). Participants often used the app as needed, eschewing its use if they felt comfortable conducting the test and interpreting its results. Seventy-eight percent would recommend the app to a friend. Availability of the INSTI Multiplex as a self-test with the accompanying SMARTtest app might increase frequency of HIV and syphilis testing, allowing for earlier detection of infection and reduced transmission.

RESUMEN: El uso de pruebas rápidas caseras con parejas y como auto-pruebas puede reducir la transmisión del VIH y la sifilis al detectar infecciones no diagnosticadas. Cuarenta y ocho hombres cisgénero y mujeres transgénero que tienen sexo con hombres recibieron diez kits del INSTI Multiplex y descargaron la aplicación SMARTtest para facilitar su uso con parejas y para auto-pruebas durante los próximos tres meses. Treinta y siete (77%) participantes se auto-testearon utilizando el INSTI (media = 3.7 veces, DE = 3.9); 26 (54%) testearon a sus parejas (media = 1.6 veces, DE = 2.2). A los participantes les gustó la prueba por su facilidad de uso, rapidez de los resultados y por ser una prueba dual de VIH/sífilis, pero al ser una prueba basada en sangre dificultó su uso con parejas. Los participantes con resultados de sífilis reactivos siempre atribuyeron éstos a una infección pasada y sus resultados presentaron un desafío para el uso de pruebas con parejas. La mayoría de los participantes afirmaron que utilizarían el INSTI como auto-pruebas (100%) y para testear a sus parejas (89%). La aceptabilidad de la aplicación SMARTtest fue alta para la funcionalidad (M = 4.16 de un máximo de 5, SD = 0.85) y utilidad (M = 6.13 de un máximo de 7, SD = 1.09). Los participantes solían utilizar la aplicación según fuera necesario, evitando su uso si se sentían cómodos realizando la prueba e interpretando sus resultados. El 78% recomendaría la aplicación a un amigo. La disponibilidad del INSTI Multiplex como auto-prueba con la aplicación SMARTtest podría aumentar la frecuencia de las pruebas de VIH y sífilis, lo que permite una detección más temprana de la infección y reduce la transmisión.