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.

Text Messaging and Disaster Preparedness Aids Engagement, Re-Engagement, Retention, and Communication Among Puerto Rican Participants in a Human Immunodeficiency Virus (HIV) Self-Testing Study After Hurricanes Irma and Maria.

OBJECTIVE: Hurricanes can interrupt communication, exacerbate attrition, and disrupt participant engagement in research. We used text messaging and disaster preparedness protocols to re-establish communication, re-engage participants, and ensure retention in a human immunodeficiency virus (HIV) self-test study. METHODS: Participants were given HIV home test kits to test themselves and/or their non-monogamous sexual partners before intercourse. A daily text message-based short message service computer-assisted self-interview (SMS-CASI) tool reminded them to report 3 variables: (1) anal sex without a condom, (2) knowledge of partners' testing history, and (3) proof of partners' testing history. A disaster preparedness protocol was put in place for hurricanes in Puerto Rico. We analyzed 6315 messages from participants (N = 12) active at the time of Hurricanes Irma and Maria. Disaster preparedness narratives were assessed. RESULTS: All participants were able to communicate sexual behavior and HIV testing via SMS-CASI within 30 days following María. Some participants (n = 5, 42%) also communicated questions. Re-engagement within 30 days after the hurricane was 100% (second week/89%, third week/100%). Participant re-engagement ranged from 0-16 days (average = 6.4 days). Retention was 100%. CONCLUSIONS: Daily SMS-CASI and disaster preparedness protocols helped participant engagement and communication after 2 hurricanes. SMS-CASI responses indicated high participant re-engagement, retention, and well-being.

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.

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.

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.

Methods, system errors, and demographic differences in participant errors using daily text message-based short message service computer-assisted self-interview (SMS-CASI) to measure sexual risk behavior in a RCT of HIV self-test use.

BACKGROUND: Assessment of sexual risk behavior is crucial to HIV prevention trials. Currently, there are no biomarkers or objective measures to detect and characterize sexual risk behavior; therefore, we must rely on self-reports. Self-report accuracy may be improved by collecting data in real-time. Our objective was to demonstrate how a text message-based short message service computer-assisted self-interview (SMS-CASI) system can collect daily sexual risk behavior data. METHODS: During the course of a 2-arm randomized controlled trial, confidential daily SMS-CASI was used to assess sexual risk behavior over three months for participants using only condoms in the control condition and using condoms and HIV self-tests to test themselves and their non-monogamous sexual partner over six months for participants in the intervention condition (total N=272). Active monitoring of participants responses and data cleaning took place concurrently with trial execution. Descriptive statistics were used to examine frequencies related to system functionality, participant reporting, system errors, communication patterns, and overall feasibility of using the SMS-CASI system for reporting sexual risk behavior. RESULTS: The SMS-CASI system processed 272,565 messages. In addition, 87 classifications of metadata were collected, for a total of 22,895,460 different data points. Types of messages included these sent (N=171,749; 63.01%) to participants, received (N=100,646; 36.93%) from participants, and failed (N=168; 0.06%) to be sent. Most errors (N=1,858) were due to system malfunctions (N=535; 28.79%) or participants' mistakes (N=1,289; 69.38%). Participant errors included: wrong password, incomplete surveys, and invalid response. The highest error rates by demographic characteristics were by age among older participants [ages 30-39; 383 errors (29.71%), and 40-69; 545 errors (42.28%)] and by race among Hispanic/Latino participants [487 errors (37.78%)]. CONCLUSIONS: The SMS-CASI system was effective at confidentially collecting sexual risk behavior data on a daily basis, potentially contributing to reduced recall and social desirability bias. This study provides methodological examples and data demonstrating how SMS-CASI can be used for sexual health data collection.

Limited Knowledge and Lack of Screening for Acute HIV Infection at Primary Care Clinics in High-Prevalence Communities of New York City.

Diagnosis and treatment of acute HIV infection (AHI) is crucial for ending the HIV epidemic. Individuals with AHI, who have high viral loads and often are unaware of their infection, are more likely to transmit HIV to others than those with chronic infection. In preparation for an educational intervention on AHI in primary health care settings in high HIV-prevalence areas of New York City, 22 clinic directors, 313 clinic providers, and 220 patients were surveyed on their knowledge and awareness of the topic from 2012-2015. Basic HIV knowledge was high among all groups while knowledge of AHI was partial among providers and virtually absent among patients. Inadequate knowledge about this crucial phase of HIV may be impeding timely identification of cases in the primary care setting.

Decentralisation of Brazil's HIV/AIDS programme: intended and unintended consequences.

Brazil's response to the HIV/AIDS epidemic was characterised by an innovative alliance of governmental and non-governmental actors inspired by a strong progressive tradition in public health. Brazil eventually moved to decentralise HIV/AIDS programmes to its states and cities, a policy endorsed and supported financially by the World Bank as consistent with the mix of public and private elements central to the country's HIV/AIDS strategy. However, decentralisation has not provided the results anticipated. Through interviews with key informants, government officials and patient advocates as well as observation of treatment sites, we outline how the shift of administration and resources to state and municipal bodies operated in practice. The Bank promoted decentralisation as an uncontroversial technical matter, and its programmatic guidelines implied that the nonprofit sector would be strengthened by it. However, instead of bringing HIV/AIDS policy closer to the grassroots, decentralisation has undermined the country's early work and opened the door to a rejuvenated epidemic by empowering unsympathetic local elites, marginalising the human rights focus, and removing federal oversight. Its experience holds crucial lessons for developing countries facing similar conditions.

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.

High Substance Use and HIV Risk Behavior Among Young Argentine Men Who Have Sex with Men.

In the United States young men who have sex with men have higher rates of substance use, higher HIV incidence, and less frequent HIV testing than their heterosexual counterparts and older MSM. Less is known about comparable populations in Latin America. As part of an epidemiological study, MSM were recruited through Respondent Driven Sampling in the metropolitan area of Buenos Aires, Argentina and answered a computerized behavioral survey. From the total of 500 MSM enrolled, a sub-sample of 233 aged 18-25 was analyzed. The sample was concentrated among lower socioeconomic strata, and only 16% identified as gay. Nearly half reported male, female, and transvestite sexual partners. Reported substance use was widespread ranging from 61% for marijuana to 20% for pasta base (cocaine sulfate). Seventy percent of the sample had never been tested for HIV infection; 3% tested positive for HIV and 8% for syphilis during the study.

Fingerprick Versus Oral Swab: Acceptability of Blood-Based Testing Increases If Other STIs Can Be Detected.

Self-testing has untapped potential as a strategy to improve access to HIV testing and to increase testing frequency. User acceptability of self-administered oral swab HIV tests is consistently high in both hypothetical and actual-use studies. We explored preferences for oral versus fingerprick HIV self-tests among men who have sex with men with a high risk profile. Participants indicated greater likelihood of using an oral swab over a blood-based test, notwithstanding lower price or quicker results from the latter. However, the likelihood of using an HIV fingerprick test substantially increased if it also offered information on other sexually transmitted infections.

Adaptation of a Couple-Based HIV/STI Prevention Intervention for Latino Men Who Have Sex With Men in New York City.

Predominantly Spanish-speaking Latino men who have sex with men (MSM) and their same-sex partners continue to be at high risk for HIV and STIs. Behavioral research has identified how relationship dynamics for male couples are associated with sexual risk behavior. Connect 'n Unite (CNU), an evidence-based HIV/STI prevention intervention originally created for Black MSM and their same-sex partners, was adapted for predominantly Spanish-speaking Latino MSM and their same-sex partners on the assumption that its key elements would be translatable while its efficacy would be retained. A systematic adaptation process utilizing qualitative methods was used, including intervention adaptation sessions with 20 predominantly Spanish-speaking Latino gay couples and 10 health service providers. The process included five steps: (1) engaging community stakeholders, (2) capturing the lived experiences of Latino gay couples, (3) identifying intervention priorities, (4) integrating the original intervention's social cognitive theory into a relationship-oriented, ecological framework for Latino gay couples, and (5) adapting intervention activities and materials. The adapted intervention, which we called Latinos en Pareja or Latinos in a Relationship, incorporates elements that effective HIV prevention interventions share, including: a solid theoretical foundation; emphasis on increasing risk reduction norms, sexual communication skills and social support for protection; and guidance on how to utilize available, culturally and linguistically appropriate services. The systematic adaptation approach used for a couples-based HIV prevention intervention also can be employed by other researchers and community stakeholders to adapt evidence-based interventions that promote wellness, linkage to care, and disease prevention for populations not originally targeted.

Lessons for Rectal Microbicide Development From an Acceptability Trial of a Placebo Gel Applied Prior to Receptive Anal Intercourse.

Rectal microbicides, formulated as a gel to be applied before and/or after intercourse, are promising HIV prevention agents and are now in Phase II trials. However, both an optimal formulation and a practical delivery system are needed to ensure that the target population will use the product once efficacy is demonstrated. The precise dynamics of lubricant application by gay and bisexual men who practice anal sex and the qualities they seek in these products are underexplored. As part of a Phase I microbicide acceptability and adherence study conducted in one Puerto Rican and two continental U.S. cities, we recruited 124 young men who have sex with men (YMSM) with a history of unprotected receptive anal intercourse (RAI) and provided them with 40 rectal applicators containing a placebo gel to use prior to RAI during a 12-week period as a proxy for an eventual rectal microbicide. Ninety-five YMSM completed the trial. Their varied preferences as to product viscosity, durability, residue, and mode of application provide important lessons for the design of a product that will be satisfactory to users. Despite many reservations, the participants used the product frequently and found ways to overcome a range of obstacles. A successful rectal microbicide product may need to be presented in a range of viscosities to attract a broad client base.

Reseña del estudio "LINKS": Factores asociados a la infección por VIH en hombres que tienen sexo con hombres de Buenos Aires, Argentina / Review of the "LINKS" study: Factors associated with HIV infection in men who have sex with men in Buenos Aires, Argentina

Este artículo resume resultados publicados del proyecto LINKS. Un to-tal de 500 hombres que tienen sexo con hombres se incluyeron en un estudio de factores asociados a la infección por VIH, utilizando la meto-dología de Muestreo Dirigido por los Participantes (Respondent Driven Sampling, RDS, en inglés). El 24,5 % se identificó como homosexual, 36,2 % como bisexual, 21,9 % como heterosexual y 17,4 % como "otro". El 33 % de los participantes reportó haber tenido relaciones sexuales con hombres, mujeres y mujeres trans durante los 2 meses previos. La prevalencia de VIH, hepatitis B y sífilis fue de 17,3 %, 22,9 % y 20,5 %, respectivamente. Los participantes que sólo reportaron parejas sexua-les masculinas tuvieron prevalencias significativamente mayores. Más de dos tercios reportaron coito anal o vaginal sin protección durante los últimos dos meses. El 52 % nunca se había realizado el diagnóstico de VIH. El 25 % informó consumo ex-cesivo de alcohol y 34 % poli-consumo de drogas du-rante los dos meses previos. El 18 % de participantes reportó una experiencia sexual antes de los 13 años con una pareja al menos cuatro años mayor de edad. La aceptabilidad de los microbicidas y de la prueba casera del VIH fue alta

Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women.

OBJECTIVES: The purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection. METHODS: MSM and TGW aged 18-30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel. RESULTS: 248 participants were enrolled into Stage 1A. Participants' average age was 23.3 years. The most common sexually transmitted infection (STIs) at baseline were Herpes simplex (HSV)-2 (16.1% by serology) and rectal Chlamydia trachomatis (CT) (10.1% by NAAT). 134 participants were enrolled into Stage 1B. During the 12 week period of follow-up 2 HIV, 5 rectal CT, and 5 rectal Neisseria gonorrhea infections were detected. The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69.6%) or moderate (28.0%). Of the participants who completed Stage 1B, 24 were enrolled into Stage 2 and randomized (1:1) to receive TFV or placebo gel. All participants completed Stage 2. The majority of AEs were gastrointestinal (N = 10) and of mild (87.2%) or moderate (10.3%) severity. CONCLUSIONS: In this study we were able to enroll a sexually active population of young MSM and TGW who were willing to use rectal microbicides. TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT01283360.

Acceptability of Three Novel HIV Prevention Methods Among Young Male and Transgender Female Sex Workers in Puerto Rico.

Sex workers need HIV-prevention methods they can control and incorporate easily in their work. We studied the acceptability of three methods: HIV self-test use with clients, oral pre-exposure prophylaxis (PrEP), and rectal microbicide gel. Four male and eight transgender female (TGF) sex workers in Puerto Rico completed a baseline survey with a quantitative measure of likelihood of use. From them, one male and four TGF also completed a 12-week study of rectal microbicide placebo gel use prior to receptive anal intercourse with male clients and evaluated via qualitative in-depth interviews and follow-up quantitative assessments how each method could be incorporated into their work. Most were interested in a rectal microbicide gel and able to use it covertly with clients. Challenges to using the HIV self-test with clients included the potential for both breach of confidentiality and confronting violent situations. Participants also expressed interest in oral PrEP, but raised concerns about side effects.

Integration of Social, Cultural, and Biomedical Strategies into an Existing Couple-Based Behavioral HIV/STI Prevention Intervention: Voices of Latino Male Couples.

INTRODUCTION: Successful HIV prevention and treatment requires evidence-based approaches that combine biomedical strategies with behavioral interventions that are socially and culturally appropriate for the population or community being prioritized. Although there has been a push for a combination approach, how best to integrate different strategies into existing behavioral HIV prevention interventions remains unclear. The need to develop effective combination approaches is of particular importance for men who have sex with men (MSM), who face a disproportionately high risk of HIV acquisition. MATERIALS AND METHODS: We collaborated with Latino male couples and providers to adapt Connect 'n Unite, an evidence-based intervention for Black male couples, for Latino male couples. We conducted a series of three focus groups, each with two cohorts of couples, and one focus group with providers. A purposive stratified sample of 20 couples (N = 40, divided into two cohorts) and 10 providers provided insights into how to adapt and integrate social, cultural, and biomedical approaches in a couples-based HIV/AIDS behavioral intervention. RESULTS: The majority (N = 37) of the couple participants had no prior knowledge of the following new biomedical strategies: non-occupational post-exposure prophylaxis (nPEP); pre-exposure prophylaxis (PrEP); and HIV self-testing kits. After they were introduced to these biomedical interventions, all participants expressed a need for information and empowerment through knowledge and awareness of these interventions. In particular, participants suggested that we provide PrEP and HIV self-testing kits by the middle or end of the intervention. Providers suggested a need to address behavioral, social and structural issues, such as language barriers; and the promotion of client-centered approaches to increase access to, adaptation of, and adherence to biomedical strategies. Corroborating what couple participants suggested, providers agreed that biomedical strategies should be offered after providing information about these tools. Regarding culturally sensitive and responsive approaches, participants identified stigma and discrimination associated with HIV and sexual identity as barriers to care, language barriers and documentation status as further barriers to care, the couple-based approach as ideal to health promotion, and the need to include family topics in the intervention. DISCUSSION: We successfully adapted an evidence-based behavioral HIV prevention intervention for Latino male couples. The adapted intervention, called Conectando Latinos en Pareja, integrates social, cultural, behavioral and biomedical strategies to address the HIV epidemic among Latino MSM. The study highlights the promise regarding the feasibility of implementing a combination approach to HIV prevention in this population.