A Mixed-Methods Approach to Develop a Combined Model of U.S. College Student Alcohol-Associated Condomless Sex.

Unhealthy alcohol use and sexually transmitted infections (STIs) are significant public health concerns for US college students. Because alcohol use and condomless sex often co-occur in this population, alcohol-associated condomless sex has been identified as a behavioral intervention target. Existing theoretical frameworks have not garnered sufficient empirical support to serve as the foundation for interventions. The primary goal of the current study was to use a mixed-methods approach to develop a model of college student alcohol-associated condomless sex that combines elements from well-established health behavior theories. In Aim 1, multilevel modeling was used to predict condomless vaginal sex in a sample of heterosexual college student drinkers (N = 53). Aim 2 consisted of in-depth interviews (n = 18) to gather perceptions about the role of alcohol in sexual activity and identify supplemental constructs omitted from theories in Aim 1. The multilevel model explained a significant proportion of variance in condomless vaginal sex at the between- and within-person level. Themes derived from the in-depth interviews identified complementary elements of condom use decision-making. Findings from both aims were synthesized to construct a combined model of alcohol-associated condomless sex. This model can be further refined and ultimately serve as the foundation of an alcohol-STI prevention-intervention.

Daily Associations Between Alcohol Consumption and Antiretroviral Therapy (ART) Adherence Among HIV-Positive Men Who Have Sex With Men.

Alcohol consumption is one of the strongest predictors of suboptimal adherence to antiretroviral therapy (ART), however, there is little research that has investigated both within- and between-person associations of alcohol consumption and ART adherence at the event-level. In this secondary data-analysis, (N = 22) HIV-positive MSM prospectively reported daily alcohol consumption and ART adherence for 42-days. Multilevel models demonstrated (1) days in which participants reported consuming any alcohol was associated with 2.48 increased odds of ART non-adherence, compared to days in which participants reported no alcohol consumption, and (2) there was a non-significant trend indicating days in which participants reported consuming greater than their own average levels of alcohol was associated with increased odds of ART non-adherence. Findings highlight the importance of combining intervention efforts that address alcohol consumption and suboptimal ART adherence, and indicate a need for future research to investigate the mechanisms by which alcohol influences ART adherence.

Development of a Telephone-Delivered Acceptance and Commitment Therapy Intervention for People Living with HIV who are Hazardous Drinkers.

Alcohol use among people living with HIV (PWH) has been increasingly recognized as an important component of HIV care. Transdiagnostic treatments, such as Acceptance and Commitment Therapy (ACT), that target core processes common to multiple mental health and substance-related problems, may be ideal in HIV treatment settings where psychological and behavioral health comorbidities are high. In advance of a randomized clinical trial (RCT), the overall objective of this study was to systematically adapt an ACT-based intervention originally developed for smoking cessation, into an ACT intervention for PWH who drink at hazardous levels. Consistent with the ADAPT-ITT model, the adaptation progressed systematically in several phases, which included structured team meetings, three focus group discussions with PWH (N = 13), and in-depth interviews with HIV providers (N = 10), and development of standardized operating procedures for interventionist training, supervision, and eventual RCT implementation. The procedures described here offer a template for transparent reporting on early phase behavioral RCTs.

Framed Messages to Increase Condom Use Frequency Among Individuals Taking Daily Antiretroviral Medication for Pre-exposure Prophylaxis.

PrEP delivery and routine care provide a unique opportunity to promote sexually transmitted infection (STI) prevention by both increasing STI testing frequency and creating a space for affirmative and effective safer sex counseling. This study was a feasibility and acceptability pilot of an adapted framed message intervention to increase condom use frequency with PrEP. In the formative phase, two focus groups with PrEP users (N = 7) provided feedback on a provisional loss-framed message intervention and identified potential study barriers. In the pilot trial, the adapted loss-framed message intervention was compared to a gain-framed message intervention and enhanced skills condition in a sample of PrEP users (N = 29). In terms of intervention feasibility, 58% of approached PrEP users completed the eligibility screen; 79% of those eligible enrolled in the study and 66% of enrolled participants completed the three-month follow-up. In terms of intervention acceptability, participants found the informational messages, regardless of assignment, to be moderately interesting (M = 6.24, SD = 2.97) and useful (M = 7.07, SD = 3.00), and very easy to understand (M = 9.50, SD = 0.97) on Likert-type scales ranging from 1 to 10. In terms of intervention effects, there was a small effect of the gain-framed intervention (b = .58, SE = .93, CI = -1.33, 2.48, Cohen's d = .26) on HIV/STI risk transmission. There was a small-medium effect of both the loss- (b = 2.00, SE = .90, CI = .15, 3.85, Cohen's d = 1.46) and gain-framed (b = 2.24, SE = .93, CI = .34, 4.15, Cohen's d = 1.65) interventions on condom use motivation. Finally, there was a medium-large effect of both the loss- (b = .97, SE = 1.33, CI = -1.88, 3.82, Cohen's d = .54) and gain-framed intervention (b = 1.97, SE = 1.33, CI = -.88, 4.82, Cohen's d = .87) on condom use frequency. Further refinement and testing, in a larger -scale trial with higher ecological validity than this initial pilot intervention, is warranted.

Then We Looked at His Results: Men Who Have Sex With Men from New York City and Puerto Rico Report Their Sexual Partner's Reactions to Receiving Reactive HIV Self-Test Results.

Secondary distribution of HIV self-tests to sexual partners is acceptable but concerns remain about reactions if a partner tests HIV-positive. We report on 14 participants whose sexual partners tested HIV-positive during the "I'll Show You Mine" Study, a randomized controlled trial (N = 272) of HIV self- and partner-testing among men who have sex with men (MSM) and transgender women (TGW). All 14 were MSM and racial/ethnic minorities, mean age was 36.6 years; 86% were gay-identified. Twenty-four partners tested positive; about half were new partners. Six participants had multiple partners test positive. During in-depth interviews with 10 of these participants, they reported their partners' reactions ranged from tearful and worried among those whose result was unexpected, to resignation among those who suspected a positive result, to nonchalance among partners who participants concluded knew of their HIV infection. After testing, some HIV-positive partners disclosed prior knowledge of their status. No partner reacted violently. Participants typically comforted their partners and encouraged confirmatory testing. Four participants had anal intercourse with partners who tested positive. Participants and partners were able to effectively handle situations in which the partner tested HIV-positive.

Substance Use and Testing Sexual Partners Using HIV Self-tests.

HIV self-tests (HIVST) provide the possibility of testing partners prior to sexual activity. This study examines the role of substance use among men who have sex with men (n = 123) and transgender women (n = 13) who were provided HIVST to use with potential sex partners. Several reported avoiding/delaying alcohol (44%) or drug use (27%) because they intended to use HIVST. Those who used HIVST with alcohol (37%) or drugs (24%) did not differ from those who did not on number of partners asked, proportion who agreed, or intentions to use HIVST. A minority reported problems caused by substances. Ten did not ask someone to test because they were too drunk/high. Fourteen said it was fairly or very hard to use HIVST when under the influence. Eleven reported substances caused problems when discussing or administering HIVST, but only two of those felt the problems were major.

Using an HIV Self-test Kit to Test a Partner: Attitudes and Preferences Among High-Risk Populations.

For those most at risk of contracting HIV, new strategies for preventing transmission and increasing testing are needed. As part of a multi-site, randomized, controlled trial, we explored attitudes and preferences among 272 HIV-negative men who have sex with men and HIV-negative transgender women using an HIV self-testing (HIVST) kit to test partners. Less than one quarter had previously self-tested with HIVST kits (21.7%) and few had partner-tested (4.8%). Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%). Five percent reported difficulties performing the test, four percent with storage, and 26% with portability. Ninety-three percent reported likelihood of using HIVST to test partners in future, but only 3% were willing to pay the current price. Efforts to improve HIVST uptake should focus on incorporating testing for other STIs, reducing test kit size, and reducing cost.

RESUMEN: Se necesitan nuevas estrategias para prevenir la transmisión del VIH e incrementar el testeo para aquellos con mayor riesgo al contagio. Como parte de un ensayo controlado aleatorio (ECA) multicentrico, exploramos las actitudes y preferencias entre 272 hombres VIH-negativos que tienen sexo con hombres y mujeres transgenero VIH-negativos que utilizaron kits del auto-test para el VIH (HIVST) para testear a sus parejas. Menos de una cuarta parte de los participantes había utilizado HIVST para auto-testearse (21.7%), y solo pocos para testear a sus parejas (4.8%) antes del comienzo del estudio. El hisopo bucal fue preferido (96%) sobre una prueba con un pinchazo de sangre (69%) por la mayoría de los participantes pero estos preferirían la prueba de sangre si puedieran obtener resultados para otras enfermedades de transmisión sexual (ETS) (86%). Cinco por ciento reportó problemas con el uso de la prueba, 4% con el almacenamiento, y el 26% con la portabilidad. Noventa y tres por ciento reportó que utilizarían HIVST para testear a sus parejas en el futuro, pero solo 3% estaba dispuesto a pagar el precio actual. Los futuros esfuerzos para mejorar la adopción del HIVST deberían enfocarse en incorporar otras pruebas de ETS, en reducir el tamaño del kit y en reducir los costos.

Transgender Women's Experiences Using a Home HIV-Testing Kit for Partner-Testing.

HIV partner-testing (PT) may represent a unique and empowering HIV prevention strategy for groups that face structural and institutional barriers to HIV testing and care, including transgender women. We report on in-depth interviews (IDIs) with N = 10 transgender women who used HIV self-test kits for three months to screen potential sexual partners in a randomized controlled trial (iSUM; "I'll Show You Mine") that took place in New York City and San Juan, Puerto Rico. Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months). We conducted IDIs with the first N = 10 transgender women to enroll in the intervention group after three months in the study (after participants used kits with partners) to understand their experiences. Themes discussed in IDIs included: partners' reaction to HIV testing, participants' reactions to partners' test results or refusal to test, partners' own reaction to their test results, and decision-making around test use. Data were independently analyzed by two coders. Overwhelmingly, participants' experiences with PT was positive. Participants reported kits were convenient and acceptable to most partners. Transgender women felt that PT could pose additional risk for them; one woman experienced violence related to kit use. Furthermore, the availability of kits appeared to encourage participants and their partners to think about their HIV status and, in some cases, modify sexual behavior. Work suggests that HIV PT could be a viable risk-reduction strategy for transgender women.

Broaching the Topic of HIV Self-testing with Potential Sexual Partners Among Men and Transgender Women Who Have Sex with Men in New York and Puerto Rico.

Men who have sex with men (MSM) and transgender women (TGW) are highly affected by HIV and need novel prevention strategies. Using HIV self-testing (HIVST) kits to screen sexual partners may represent a viable risk-reduction alternative; however, more research is needed on effective strategies for broaching HIVST with partners. In the ISUM study, 136 MSM and TGW were given ten HIVST kits for self- and partner-testing. After 3 months, they returned for a follow-up assessment; thirty participants were also selected for in-depth interviews about their experiences initiating HIVST with partners. Most found proposing HIVST to a diverse array of partners relatively easy. They employed strategies such as joint testing and integrating HIVST into larger discussions about protection and sexual health, with moderate success. Nonetheless, real or anticipated negative partner reactions were a significant barrier. Future research can inform best practices for safely and successfully broaching HIVST with sexual partners.

RESUMEN: Los hombres que tienen sexo con hombres (HSH) y las mujeres tránsgenero (MTG) están muy afectados por el VIH y necesitan estrategias innovadoras de prevención. El uso del autotest de VIH (HIVST) para testear a parejas sexuales podría ser una alternativa viable de reducir el riesgo; sin embargo, se necesitan más investigaciones sobre estrategias eficaces para abordar el tema de usar el HIVST con parejas. En el estudio ISUM, 136 HSH y MTG fueron provistos de diez HIVST para testear a sí mismo y a parejas. Después de tres meses, volvieron para una evaluación de seguimiento; treinta participantes también fueron seleccionados para una entrevista en profundidad sobres sus experiencias abordando el tema del uso del HIVST con parejas. La mayoría encontró que proponer HIVST a una gran variedad de parejas fue relativamente fácil. Emplearon estrategias como hacerse la prueba juntos y integrar HIVST en una conversación más amplia sobre la protección y la salud sexual, con leve éxito. No obstante, las reacciones negativas de parejas, ya sean reales o anticipadas, representaron una barrera importante. Las investigaciones futuras pueden informar las mejores prácticas para abordar el tema de HIVST con parejas sexuales de manera segura y exitosa.

Few Aggressive or Violent Incidents are Associated with the Use of HIV Self-tests to Screen Sexual Partners Among Key Populations.

Men who have sex with men and transgender women who had multiple sexual partners in the prior 3 months participated in ISUM, a randomized, controlled trial of self- and partner-testing in New York City and San Juan, PR. Only 2% of screened participants were ineligible to enroll due to anticipating they would find it very hard to avoid or handle violence. The intervention group received free rapid HIV self-test kits. During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner. Only 6% of participants who asked a partner in person to test reported that at least one of their partners got physically violent, some in the context of sex work. In total, 16 (2%) partners reacted violently. Post-trial, only one participant reported finding it very hard to handle violence, and none found it very hard to avoid potential violence.

Use of Rapid HIV Self-Test to Screen Potential Sexual Partners: Results of the ISUM Study.

ISUM ("I'll show you mine") was a randomized controlled trial in which 272 transgender women and men who have sex with men in New York, NY (NYC) and San Juan, Puerto Rico (SJU) were assigned to an intervention group (n = 136), in which they had access to free HIV self-testing (ST) kits, or to a control group (n = 136). The trial aimed to determine whether the intervention group would use ST to screen sexual partners and have fewer condomless anal intercourse (CAI) occasions with serodiscordant or unknown status partners than the control group. The intervention group had on average 10 (32%) fewer CAI occasions; though clinically relevant, this difference fell short of statistical significance (p = .08). In NYC (n = 166) intervention participants had significantly fewer CAI occasions, whereas in SJU (n = 106) they reported non-significantly more CAI occasions. Two devastating hurricanes hit SJU during the study and may have impacted results in unmeasured ways.

Use of HIV Self-Testing Kits to Screen Clients Among Transgender Female Sex Workers in New York and Puerto Rico.

Transgender female sex workers (TFSW) are highly affected by HIV, with a global prevalence of 27%. HIV self-testing (HIVST) to screen sexual partners has helped men who have sex with men and female sex workers make informed sexual decisions and avoid HIV exposure. This is the first report on TFSW's experiences screening clients using HIVST. Ten TFSW were each given ten HIVST kits and returned after 3 months to complete an online questionnaire and undergo an interview. Eight of them reported using HIVST with potential partners. Among fifty potential partners who were asked in person to test, 42 (84%) were clients. Thirty-four out of fifty (68%) accepted and 16 (32%) refused. Very few violent incidents occurred, and participants felt empowered by offering HIVST to others. Nevertheless, HIVST market cost was prohibitive for future use. HIVST use with clients could be feasible for TFSW if the cost were lowered or subsidized.

Information and Motivation Predict HIV-Serostatus Among a Population of High-Risk Men and Transgender Women Who Have Sex with Men.

Two constructs from the information-motivation-behavioral skills model were used to predict HIV-serostatus among a sample of men and transgender women who have sex with men. Hypotheses were that lower levels of HIV knowledge and lower levels of motivation to remain HIV-negative would be associated with an increased likelihood of receiving a positive HIV test result at a study eligibility-screening session. Results of a backwards stepwise logistic regression analysis demonstrated that lower levels of HIV knowledge, lower levels of motivation to remain HIV-negative, lower levels of education, and identifying as Hispanic/Latinx were associated with greater odds of receiving a positive HIV test result. These findings are consistent with the broader HIV-prevention literature that demonstrates that information and motivation are fundamental determinants of HIV preventive behavior. This work has implications for informing the development and improvement of HIV-prevention interventions.

Assessing the interaction between depressive symptoms and alcohol use prior to antiretroviral therapy on viral suppression among people living with HIV in Rural Uganda.

Although there is evidence of individual associations between depressive symptoms and hazardous alcohol use with suboptimal antiretroviral therapy (ART) adherence among people living with HIV (PLWH), few studies have established how the two risk factors may interact to predict viral suppression. We conducted secondary data analyses with two cohorts of Ugandan PLWH (N = 657) to investigate the hypothesized interaction between depressive symptoms (Center for Epidemiological Studies Depression Scale) and hazardous alcohol use (Alcohol Use Disorder Identification Test -Consumption and/or Phosphatidylethanol biomarker) prior to ART initiation with viral suppression (<550 copies/ml). We were unable to detect an interaction between depressive symptoms and hazardous alcohol use prior to ART initiation with viral suppression in the first two years (M = 19.9 months) after ART initiation (p = 0.75). There was also no evidence of a main effect association for depressive symptoms (Adjusted Odds Ratio [AOR] = 0.88, 95% Confidence Interval [CI]: 0.50, 1.55) or hazardous alcohol use (AOR = 1.37, 95% CI: 0.80, 2.33). PLWH with depressive symptoms and/or hazardous alcohol use appear to exhibit similar levels of viral suppression as others in care; further work is needed to determine effects on HIV testing and treatment engagement.

Association of Depressive Symptoms with Lapses in Antiretroviral Medication Adherence Among People Living with HIV: A Test of an Indirect Pathway.

Viral suppression, a critical component of HIV care, is more likely when individuals initiate antiretroviral therapy (ART) early in disease progression and maintain optimal levels of adherence to ART regimens. Although several studies have documented the negative association of depressive symptoms with ART adherence, less is known about how depressed mood relates to intentional versus unintentional lapses in adherence as well as the mechanisms underlying this association. The purpose of the current study was to examine the association of depressive symptoms with ART adherence, assessed as a multidimensional construct. Secondarily, this study conducted preliminary indirect path models to determine if medication self-efficacy could explain the depressed mood-adherence relationship. Depressive symptoms were not associated with 95% ART taken, self-reported viral load, deliberate adjustments to ART regimens or skipped ART doses. However, the indirect association of depressive symptoms via decrements in medication self-efficacy was significant for 95% ART taken, self-reported viral load and skipped ART doses, but not deliberate changes to ART regimens. In this sample of HIV-positive outpatients, there is evidence to support medication self-efficacy as a potential mechanism underlying the association between depressive symptoms and ART adherence. Additional longitudinal studies are needed to formally examine medication taking self-efficacy as a mediator.

Correction to: Association of Depressive Symptoms with Lapses in Antiretroviral Medication Adherence Among People Living with HIV: A Test of an Indirect Pathway.

The original version of this article unfortunately contained a mistake in Fig. 1. The figure was incorrectly presented with the results of an additional path model for forgotten antiretroviral therapy (ART) doses that was dropped from the primary analyses.

Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial.

Adherence to product use in biomedical HIV prevention trials is essential to success. In MTN-017, a Phase 2 rectal microbicide gel trial, participants discussed applicator-inserted gel use in the context of receptive anal intercourse (RAI) with adherence counselors. We analyzed counseling session data to identify barriers to and facilitators of gel use for 26 participants in the United States who used gel with RAI as their first of three study regimens. The most common barriers were finding the gel application process cumbersome, physical discomfort after applying gel, difficulty with BAT-24 dosage regimen, and negative effects of gel on sex. The most common facilitators were incorporating gel use into routines, using gel in anticipation of sex, carrying gel when going out, reminders received via short message service, and ease of gel use. These findings can inform product development and future adherence counseling interventions for rectal gel trials to improve adherence outcomes.

Mixed-Method Evaluation of Social Media-Based Tools and Traditional Strategies to Recruit High-Risk and Hard-to-Reach Populations into an HIV Prevention Intervention Study.

Men who have sex with men and transgender women are hard-to-reach populations for research. Social media-based tools may overcome certain barriers in accessing these groups and are being tested in an ongoing study exploring HIV home-test kit use to reduce risk behavior. We analyzed pre-screening responses about how volunteers learned about the study (n = 896) and demographic data from eligible participants who came for an initial study visit (n = 216) to determine the strengths and weaknesses of recruitment strategies. Social media-based strategies resulted in the highest number of individuals screened (n = 444, 26% eligible). Dating sites/apps reached large numbers of eligible participants. White-Hispanics and African-Americans were more likely to be recruited through personal contacts; community events successfully reached Hispanic volunteers. Incorporating recruitment queries into pre-screening forms can help modify recruitment strategies for greater efficacy and efficiency. Findings suggest that recruitment strategies need to be tailored to reach specific target populations.

Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017).

BACKGROUND: We implemented a text message-based Short Message Service computer-assisted self-interviewing (SMS-CASI) system to aid adherence and monitor behavior in MTN-017, a phase 2 safety and acceptability study of rectally-applied reduced-glycerin 1% tenofovir gel compared to oral emtricitabine/tenofovir disoproxil fumarate tablets. We sought to implement SMS-based daily reminders and product use reporting, in four countries and five languages, and centralize data management/automated-backup. METHODS: We assessed features of five SMS programs against study criteria. After identifying the optimal program, we systematically implemented it in South Africa, Thailand, Peru, and the United States. The system consisted of four windows-based computers, a GSM dongle and sim card to send SMS. The SMS-CASI was, designed for 160 character SMS. Reminders and reporting sessions were initiated by date/time triggered messages. System, questions, responses, and instructions were triggered by predetermined key words. RESULTS: There were 142,177 total messages: sent 86,349 (60.73%), received 55,573 (39.09%), failed 255 (0.18%). 6153 (4.33%) of the message were errors generated from either our SMS-CASI system or by participants. Implementation challenges included: high message costs; poor data access; slow data cleaning and analysis; difficulty reporting information to sites; a need for better participant privacy and data security; and mitigating variability in system performance across sites. We mitigated message costs and poor data access by federating the SMS-CASI system, and used secure email protocols to centralize data backup. We developed programming syntaxes to facilitate daily data cleaning and analysis, and a calendar template for reporting SMS behavior. Lastly, we ambiguated text message language to increase privacy, and standardized hardware and software across sites, minimizing operational variability. CONCLUSION: We identified factors that aid international implementation and operation of SMS-CASI for real-time adherence monitoring. The challenges and solutions we present can aid other researchers to develop and manage an international multilingual SMS-based adherence reminder and CASI system.

Identifying Strategies to Cope with HIV-Related Stigma in a Group of Women Living with HIV/AIDS in the Dominican Republic: A Qualitative Study.

Internalized HIV-related stigma negatively impacts the mental and physical health of women living with HIV/AIDS (WLWHA). Yet, some women can successfully confront stigma. The present work uses qualitative methods to investigate the successful stigma coping strategies displayed by 19 WLWHA who reported the least internalized stigma possible on the Internalized AIDS-Related Stigma Scale out of a larger pool of 233 WLWHA in San Felipe de Puerto Plata, Dominican Republic. Such strategies included, HIV disclosure control; preemptive disclosure of HIV-status; educating oneself/others about HIV; viewing HIV as a manageable condition; and looking to family, friends and partners for support. Our findings add to current knowledge about how WLWHA successfully manage internalized stigma, particularly in the context of the Dominican Republic. Clinicians should work closely with WLWHA to counsel them about the stigma coping strategies that best fit their life context.