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Intervention to Increase HIV Testing Among Substance-Using Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Young men who have sex with men (YMSM) and transgender people in the Detroit Metro Area are the only risk group for whom the incidence of HIV and sexually transmitted infections (STI) has increased since 2000, with HIV incidence nearly doubling among youth. Substance use (including alcohol), which is relatively frequent among YMSM and transgender people, creates barriers to the optimal delivery of HIV prevention and care services. Standard HIV counseling, testing, and referral (CTR) is limited in providing strategies to identify and address substance use. Hence, in its current form, CTR may not be serving the prevention needs of substance-using YMSM and transgender people. Brief counseling interventions, grounded in principles of motivational interviewing, may offer a mechanism to meet the HIV prevention and care needs of substance-using YMSM and transgender people. OBJECTIVE:This prospective, 4-arm, factorial randomized controlled trial aims to examine the efficacy of an motivational interviewing-based substance use brief intervention (SUBI) on participants' substance use and engagement in HIV prevention. METHODS:The research implements a prospective randomized controlled trial (Project Swerve) of 600 YMSM and transgender people recruited both online and in person. Eligibility criteria include participants who (1) are between the ages of 15 to 29 years, (2) live in the Detroit Metro Area, (3) self-identify as a man or transgender man or woman, (4) have had sexual contact with a man in the 6 months before enrollment, (5) self-report binge drinking or any substance use in the 3 months before enrollment, and (6) self-report an unknown or negative HIV status upon enrollment. Participants are randomized to receive, 3-months apart starting at baseline, 2 individual sessions. Sessions are CTR-only, SUBI-only, CTR followed by SUBI, or SUBI followed by CTR. RESULTS:Project Swerve was launched in April 2017 and enrollment is ongoing. CONCLUSIONS:Incorporating a SUBI that utilizes the principles of motivational interviewing into HIV CTR provides an opportunity to tailor counseling services for YMSM and transgender people to address additional client barriers to HIV and STI testing. TRIAL REGISTRATION:ClinicalTrials.gov NCT02945436; http://clinicaltrials.gov/ct2/show/NCT02945436 (Archived by WebCite at http://www.webcitation.org/6yFyOK57w).

SUBMITTER: Stephenson R

PROVIDER: S-EPMC5952122 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Intervention to Increase HIV Testing Among Substance-Using Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

Stephenson Rob R Bonar Erin E EE Carrico Adam A Hunter Alexis A Connochie Daniel D Himmelstein Rebecca R Bauermeister Jose J

JMIR research protocols 20180430 4

<h4>Background</h4>Young men who have sex with men (YMSM) and transgender people in the Detroit Metro Area are the only risk group for whom the incidence of HIV and sexually transmitted infections (STI) has increased since 2000, with HIV incidence nearly doubling among youth. Substance use (including alcohol), which is relatively frequent among YMSM and transgender people, creates barriers to the optimal delivery of HIV prevention and care services. Standard HIV counseling, testing, and referral ...[more]

PMID: 29712625

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Project description:BackgroundMen with have sex with men (MSM) in Africa face high levels of stigma due to elevated HIV exposure (actual or perceived), same-sex practices, and gender non-conformity. These stigmas are documented barriers to HIV prevention and treatment. Most stigma-reduction interventions have focused on single-level targets (e.g., health care facility level [HCF]) and addressed one type of stigma (e.g., HIV), without engaging the multiple intersecting stigmas that MSM encounter. Determining the feasibility and acceptability of multi-level intervention of reducing intersectional stigma and estimating its efficacy on increasing HIV testing are needed.MethodsWe proposed a mixed method study among MSM in Ghana. First, we will develop the intervention protocol using the Convergence Framework, which combines three interventions that were previously implemented separately in Ghana for reducing stigma at the HCF-level, increasing HIV testing at the peer group-level, and increasing peer social support at the individual-level. Then, we will conduct a cluster randomized controlled trial with four pairs of HCFs matched on staff size. HCFs within each pair are randomized to the HCF-level stigma-reduction intervention or control arm. MSM (n = 216) will be randomized to receive the group-level and individual-level interventions or standard of care control arm. MSM will be assigned to receive HIV testing at one of the HCFs that match their study assignment (intervention or control facility). The frequency of HIV testing between MSM in the study arms at 3 and 6 months will be compared, and the predictors of HIV testing uptake at the HCF, peer group and individual-levels will be assessed using multi-level regression models.DiscussionThese findings from this study will provide important evidence to inform a hybrid implementation-effectiveness trial of a public health intervention strategy for increasing HIV case detection among key populations in sub-Saharan African communities. Accurate information on HIV prevalence can facilitate epidemic control through more precise deployment of public health measures aimed at HIV treatment and viral load suppression, which eliminates risk of transmission.Trial registrationThis study was prospectively registered on ClinicalTrials.gov, Identifier: NCT04108078, on September 27, 2019.

Project description:BackgroundHIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM.ObjectiveThe aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app.MethodsThis 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY.ResultsApp refinement is underway. Enrollment for the pilot RCT began in October 2018.ConclusionsMyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities.International registered report identifier (irrid)PRR1-10.2196/10694.

Project description:BackgroundHIV status disclosure is an important decision with barriers specific to young men who have sex with men (YMSM), who have the highest rates of new HIV infections in the United States. Behavioral and social determinants of the difficulty to disclose can include fear of rejection, stigma, loss of financial stability, and lack of communication skills. Once able to disclose, a person may have increased access to social support and improved informed risk reduction conversations and medication adherence. Despite the known challenges and advantages of disclosure, there are few effective tools supporting this behavior.ObjectiveTo address this gap in disclosure interventions, the Tough Talks (TT) app, an mHealth intervention using artificial intelligence (AI)-facilitated role-playing scenarios, was developed for YMSM. This paper reports stages of development of the integrated app and results of the usability testing.MethodsBuilding on the successful development and testing of a stand-alone interactive dialogue feature in phases 1-3, we conducted additional formative research to further refine and enhance the disclosure scenarios and develop and situate them within the context of a comprehensive intervention app to support disclosure. We assessed the new iteration for acceptability and relevance in a usability study with 8 YMSM with HIV. Participants completed a presurvey, app modules, and a semistructured qualitative interview.ResultsTT content and activities were based on social cognitive theory and disclosure process model framework and expanded to a 4-module curriculum. The AI-facilitated scenarios used dialogue from an utterance database developed using language crowdsourced through a comic book contest. In usability testing, YMSM reported high satisfaction with TT, with 98% (31/33) of activities receiving positive ratings. Participants found the AI-facilitated scenarios and activities to be representative and relevant to their lived experiences, although they noted difficulty having nuanced disclosure conversations with the AI.ConclusionsTT was an engaging and practical intervention for self-disclosure among YMSM with HIV. Facilitating informed disclosure decisions has the potential to impact engagement in sexual risk behaviors and HIV care. More information is needed about the ideal environment, technical assistance, and clinical support for an mHealth disclosure intervention. TT is being tested as a scalable intervention in a multisite randomized controlled trial to address outstanding questions on accessibility and effect on viral suppression.Trial registrationClinicalTrials.gov NCT03414372; https://clinicaltrials.gov/ct2/show/NCT03414372.

Project description:BACKGROUND:In the recent years, the Internet has been used as a medium to find sexual partners and engage in risky sexual behavior. This has changed the way in which men having have sex with men (MSM) seek sexual partners and has increased the number of high-risk sexual encounters. Therefore, developers of human immunodeficiency virus (HIV)-prevention interventions have also started using the Internet as a viable medium to promote safe sexual behaviors. However, much of the efforts thus far have been aimed at HIV-negative rather than HIV-positive MSM. HIV-positive individuals continue to engage in risky sexual behaviors and thus constitute an important group in which HIV prevention strategies need to be addressed. Therefore, HIV prevention in HIV-positive MSM is a critical issue. OBJECTIVE:Condom-Him, an Internet-based intervention tailored to increase condom use among HIV-positive MSM, was developed with the aim of improving condom use, self-efficacy, and intentions to use condoms among these individuals. The acceptability and feasibility of this Internet-based intervention will be examined in a pilot study. METHODS:We will perform a randomized controlled parallel-group superiority trial. HIV-positive MSM who currently engage in unprotected anal sex will be recruited for the study. Participants will be randomly assigned using a one-to-one allocation ratio generated by the computer program. The researchers will be blinded to participant's group assignment. Participants will be assigned either to use the Condom-Him intervention (experimental arm) or to view a list of websites containing HIV/AIDS related information (control arm). Self-administered questionnaires will be provided online before randomization (baseline) and two weeks after intervention (post-test). RESULTS:The study will include a total of 60 participants with 30 in each group. The results from this pilot study will provide further evidence for a larger study to examine the effectiveness of this intervention and will provide a cost-effective and widely accessible approach to HIV prevention for HIV-positive MSM. CONCLUSIONS:Internet-based interventions for HIV-positive MSM, a population that has been under-represented in the efforts for positive prevention of HIV within Canada, have the potential to provide a cost-effective strategy, which influences the way in which information is accessed and provided to high-risk individuals. The advantages of an Internet-based intervention include the potential to provide consistency in the delivery of an intervention and the ability to disseminate the intervention to a wider population. Internet-based interventions are perceived as vital tools in combating HIV infection within the realm of social media. Therefore, it is important to determine the feasibility and acceptability of these interventions before implementing them. TRIAL REGISTRATION:Clinicaltrials.gov: NCT01726153; http://clinicaltrials.gov/ct2/show/NCT01726153 (Archived by WebCite at http://www.webcitation.org/6Jljzip8B).

Project description:BackgroundDespite great efforts in HIV prevention worldwide, HIV testing uptake among men who have sex with men (MSM) remains suboptimal. The effectiveness of digital, crowdsourced, multilevel interventions in improving HIV testing is still unclear.ObjectiveThe aim of this study was to evaluate the effect of a digital, crowdsourced, multilevel intervention in improving HIV testing uptake among MSM in China.MethodsWe conducted a 2-arm cluster randomized controlled trial among MSM in 11 cities in Shandong province, China, from August 2019 to April 2020. Participants were men who were HIV seronegative or had unknown serum status, had anal sex with a man in the past 12 months, and had not been tested for HIV in the past 3 months. Participants were recruited through a gay dating app and community-based organizations from preselected cities; these cities were matched into 5 blocks (2 clusters per block) and further randomly assigned (1:1) to receive a digital, crowdsourced, multilevel intervention (intervention arm) or routine intervention (control arm). The digital multilevel intervention was developed through crowdsourced open calls tailored for MSM, consisting of digital intervention images and videos, the strategy of providing HIV self-testing services through digital tools, and peer-moderated discussion within WeChat groups. The primary outcome was self-reported HIV testing uptake in the previous 3 months. An intention-to-treat approach was used to examine the cluster-level effect of the intervention in the 12-month study period using generalized linear mixed models and the individual-level effect using linear mixed models.ResultsA total of 935 MSM were enrolled (404 intervention participants and 531 controls); 751 participants (80.3%) completed at least one follow-up survey. Most participants were younger than 30 years (n=601, 64.3%), single (n=681, 72.8%), had a college degree or higher (n=629, 67.3%), and had an HIV testing history (n=785, 84%). Overall, the proportion of testing for HIV in the past 3 months at the 3-, 6-, 9-, and 12-month follow-ups was higher in the intervention arm (139/279, 49.8%; 148/266, 55.6%; 189/263, 71.9%; and 171/266, 64.3%, respectively) than the control arm (183/418, 43.8%; 178/408, 43.6%; 206/403, 51.1%; and 182/397, 48.4%, respectively), with statistically significant differences at the 6-, 9-, and 12-month follow-ups. At the cluster level, the proportion of participants who had tested for HIV increased 11.62% (95% CI 0.74%-22.5%; P=.04) with the intervention. At the individual level, participants in the intervention arm had 69% higher odds for testing for HIV in the past 3 months compared with control participants, but the result was not statistically significant (risk ratio 1.69, 95% CI 0.87-3.27; P=.11).ConclusionsThe intervention effectively improved HIV testing uptake among Chinese MSM. Our findings highlight that digital, crowdsourced, multilevel interventions should be made more widely available for HIV prevention and other public health issues.Trial registrationChinese Clinical Trial Registry ChiCTR1900024350; http://www.chictr.org.cn/showproj.aspx?proj=36718.International registered report identifier (irrid)RR2-10.1186/s13063-020-04860-8.

Project description:BACKGROUND:Globally, four out of ten individuals living with HIV have not been tested for HIV. Testing is especially important for men who have sex with men (MSM), among whom an increasing HIV epidemic has been identified in many regions of the world. As a supplement to site-based HIV testing services, HIV self-testing (HIVST) provides a promising approach to promote HIV testing. However, evidence is scattered and not well-summarized on the effect of HIVST to improve HIV testing behaviors, especially for MSM. METHODS:Seven databases (PubMed, Web of Science, Cochrane Library, PsycINFO, CINAHL Plus, WanFang, and China National Knowledge Internet) and conference abstracts from six HIV/sexually transmitted infections conferences were searched from January 2000-April 2017. RESULTS:Of 1,694 records retrieved, 23 studies were identified, 9 conducted in resource-limited countries and 14 in high-income countries. The pooled results showed that HIVST increased HIV test frequency for MSM by one additional test in a 6-month period (mean difference = 0.88 [95% CI 0.52-1.24]). The pooled proportion of first-time testers among those who took HIVST was 18.7% (95% CI: 9.9-32.4) globally, with a rate 3.32 times higher in resource-limited country settings (32.9% [95% CI: 21.3-47.6]) than in high-income countries (9.9% [95% CI: 7.4-13.8]). The pooled proportions included non-recent testers, 32.9% (95% CI: 28.1-38.3); ever or currently married MSM, 16.7% (95% CI: 14.5-19.4); and HIV positive men, 3.8% (95% CI: 2.0-5.7) globally; 6.5% [95% CI: 0.38-12.3] in resource-limited country settings; and 2.9% [95% CI: 2.0-5.0] in high-income countries). The rates reported for linkage to care ranged from 31.3% to 100%. CONCLUSIONS:HIVST could increase HIV testing frequency and potentially have capacity equivalent to that of site-based HIV testing services to reach first-time, delayed, married, and HIV-infected testers among MSM and link them to medical care. However, more rigorous study designs are needed to explore the specific self-testing approach (oral-fluid based or finger-prick based) on improving HIV testing for MSM in different social and economic settings.

Project description:BackgroundRegular human immunodeficiency virus (HIV) testing of persons at risk is critical to HIV prevention. Infrequent HIV testing and late diagnosis of HIV infection have been observed among young black men who have sex with men (MSM) and transwomen (transgender women)-two groups overrepresented in the HIV epidemic.ObjectiveThe objective of this study was to inform the development of a brief mobile phone intervention to increase HIV testing among young black MSM and transwomen by providing a tailored recommendation of an optimal HIV testing approach. We identified demographic, behavioral, psychosocial, and sociostructural factors associated with intentions to use three specific HIV testing approaches: self-testing, testing at a clinic or other provider, and couples HIV testing and counseling (CHTC).MethodsIndividuals were eligible for a Web-based survey if they were male at birth; were between the ages of 16 and 29 years; self-identified as black, African American, Caribbean black, African black, or multiethnic black; were not known to be HIV-infected; and reported insertive or receptive anal intercourse with a man or transwoman in the last 12 months. Recruitment occurred via banner advertisements placed on a range of social and sexual networking websites and apps in New York City and nationally, and via events attended by young black MSM and transwomen in New York City. Intention to test by each testing method was analyzed using logistic regression with best subset models and stepwise variable selection.ResultsAmong 169 participants, intention to use a self-test was positively associated with comfort in testing by a friend or a partner at home (Adjusted odds ratio, AOR, 2.40; 95% CI 1.09-5.30), and stigma or fear as a reason not to test (AOR 8.61; 95% CI 2.50-29.68) and negatively associated with higher social support (AOR 0.48; 95% CI 0.33-0.72) and having health insurance (AOR 0.21; 95% CI 0.09-0.54). Intention to test at a clinic or other provider was positively associated with self-efficacy for HIV testing (AOR 2.87; 95% CI 1.48-5.59) and social support (AOR 1.98; 95% CI 1.34-2.92), and negatively associated with a lifetime history of incarceration (AOR 0.37; 95% CI 0.16-0.89). Intention to test by CHTC was negatively associated with higher educational level (Some college or Associate's degree vs high school graduate or less [AOR 0.81; 95% CI 0.39-1.70]; Bachelor's degree or more vs high school graduate or less [AOR 0.28; 95% CI 0.11-0.70]).ConclusionsUnique factors were associated with intention to test using specific testing approaches. These data will be critical for the development of a tailored intervention that shows promise to increase comfort and experiences with a variety of testing approaches among young black MSM and transwomen.

Dataset Information

Intervention to Increase HIV Testing Among Substance-Using Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

Publications

Intervention to Increase HIV Testing Among Substance-Using Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

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