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      Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized Controlled Trial of Keep It Up! 2.0

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          Abstract

          Background

          Human immunodeficiency virus (HIV) infections are increasing among young men who have sex with men (YMSM), yet few HIV prevention programs have studied this population. Keep It Up! (KIU!), an online HIV prevention program tailored to diverse YMSM, was developed to fill this gap. The KIU! 2.0 randomized controlled trial (RCT) was launched to establish intervention efficacy.

          Objective

          The objective of the KIU! study is to advance scientific knowledge of technology-based behavioral HIV prevention, as well as improve public health by establishing the efficacy of an innovative electronic health (eHealth) prevention program for ethnically and racially diverse YMSM. The intervention is initiated upon receipt of a negative HIV test result, based on the theory that testing negative is a teachable moment for future prevention behaviors.

          Methods

          This is a two-group, active-control RCT of the online KIU! intervention. The intervention condition includes modules that use videos, animation, games, and interactive exercises to address HIV knowledge, motivation for safer behaviors, self-efficacy, and behavioral skills. The control condition reflects HIV information that is readily available on many websites, with the aim to understand how the KIU! intervention improves upon information that is currently available online. Follow-up assessments are administered at 3, 6, and 12 months for each arm. Testing for urethral and rectal sexually transmitted infections (STIs) is completed at baseline and at 12-month follow-up for all participants, and at 3- and 6-month follow-ups for participants who test positive at baseline. The primary behavioral outcome is unprotected anal sex at all follow-up points, and the primary biomedical outcome is incident STIs at 12-month follow-up.

          Results

          Consistent with study aims, the KIU! technology has been successfully integrated into a widely-used health technology platform. Baseline enrollment for the RCT was completed on December 30, 2015 (N=901), and assessment of intervention outcomes is ongoing at 3-, 6-, and 12-month time points. Upon collection of all data, and after the efficacy of the intervention has been evaluated, we will explore whether the KIU! intervention has differential efficacy across subgroups of YMSM based on ethnicity/race and relationship status.

          Conclusions

          Our approach is innovative in linking an eHealth solution to HIV and STI home testing, as well as serving as a model for integrating scalable behavioral prevention into other biomedical prevention strategies.

          Trial Registration

          Clinicaltrials.gov NCT01836445; https://clinicaltrials.gov/ct2/show/NCT01836445 (Archived by WebCite at http://www.webcitation.org/6myMFlxnC)

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          Most cited references45

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          Family rejection as a predictor of negative health outcomes in white and Latino lesbian, gay, and bisexual young adults.

          Caitlin Ryan, David Huebner, Rafael Díaz … (2009)
          We examined specific family rejecting reactions to sexual orientation and gender expression during adolescence as predictors of current health problems in a sample of lesbian, gay, and bisexual young adults. On the basis of previously collected in-depth interviews, we developed quantitative scales to assess retrospectively in young adults the frequency of parental and caregiver reactions to a lesbian, gay, or bisexual sexual orientation during adolescence. Our survey instrument also included measures of 9 negative health indicators, including mental health, substance abuse, and sexual risk. The survey was administered to a sample of 224 white and Latino self-identified lesbian, gay, and bisexual young adults, aged 21 to 25, recruited through diverse venues and organizations. Participants completed self-report questionnaires by using either computer-assisted or pencil-and-paper surveys. Higher rates of family rejection were significantly associated with poorer health outcomes. On the basis of odds ratios, lesbian, gay, and bisexual young adults who reported higher levels of family rejection during adolescence were 8.4 times more likely to report having attempted suicide, 5.9 times more likely to report high levels of depression, 3.4 times more likely to use illegal drugs, and 3.4 times more likely to report having engaged in unprotected sexual intercourse compared with peers from families that reported no or low levels of family rejection. Latino men reported the highest number of negative family reactions to their sexual orientation in adolescence. This study establishes a clear link between specific parental and caregiver rejecting behaviors and negative health problems in young lesbian, gay, and bisexual adults. Providers who serve this population should assess and help educate families about the impact of rejecting behaviors. Counseling families, providing anticipatory guidance, and referring families for counseling and support can help make a critical difference in helping decrease risk and increasing well-being for lesbian, gay, and bisexual youth.
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            From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection.

            D. T. Fleming, J N Wasserheit (1999)
            To review the scientific data on the role of sexually transmitted diseases (STDs) in sexual transmission of HIV infection and discuss the implications of these findings for HIV and STD prevention policy and practice. Articles were selected from a review of Medline, accessed with the OVID search engine. The search covered articles from January 1987 to September 1998 and yielded 2101 articles. Methods used to uncover articles which might have been missed included searching for related articles by author, and combing literature reviews. In addition, all abstracts under the category "sexually transmitted diseases" from the XI and XII International Conferences on AIDS (Vancouver 1996 and Geneva 1998) and other relevant scientific meetings were reviewed. Efforts were made to locate journal articles which resulted from the research reported in the identified abstracts. All original journal articles and abstracts which met one of the following criteria were included: (1) studies of the biological plausibility or mechanism of facilitation of HIV infectiousness or susceptibility by STDs, (2) prospective cohort studies (longitudinal or nested case-control) which estimate the risk of HIV infection associated with specific STDs or STD syndromes, or (3) intervention studies which quantitate the effect which STD treatment can have on HIV incidence. Strong evidence indicates that both ulcerative and non-ulcerative STDs promote HIV transmission by augmenting HIV infectiousness and HIV susceptibility via a variety of biological mechanisms. These effects are reflected in the risk estimates found in numerous prospective studies from four continents which range from 2.0 to 23.5, with most clustering between 2 and 5. The relative importance of ulcerative and non-ulcerative STDs appears to be complex. Owing to the greater frequency of non-ulcerative STDs in many populations, these infections may be responsible for more HIV transmission than genital ulcers. However, the limited reciprocal impact of HIV infection on non-ulcerative STDs and the evidence that non-ulcerative STDs may increase risk primarily for the receptive partner (rather than bidirectionally) may modulate the impact of these diseases. The results of two community level randomised, controlled intervention trials conducted in Africa suggest that timely provision of STD services can substantially reduce HIV incidence, but raise additional questions about the optimal way to target and implement these services to achieve the greatest effect on HIV transmission. Available data leave little doubt that other STDs facilitate HIV transmission through direct, biological mechanisms and that early STD treatment should be part of a high quality, comprehensive HIV prevention strategy. Policy makers, HIV prevention programme managers, and providers should focus initial implementation efforts on three key areas: (i) improving access to and quality of STD clinical services; (ii) promoting early and effective STD related healthcare behaviours; and (iii) establishing surveillance systems to monitor STD and HIV trends and their interrelations.
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              Sexual orientation and adolescent substance use: a meta-analysis and methodological review.

              Michael P Marshal, Mark S Friedman, Ron Stall … (2008)
              Several decades of research have shown that lesbian, gay and bisexual (LGB) adults are at high risk for substance use and substance use disorders (SUDs). These problems may often start prior to young adulthood; however, relatively little is known about risk for substance use in LGB adolescents. The primary aims of this paper were to conduct a meta-analysis of the relationship between sexual orientation and adolescent substance use and a systematic review and critique of the methodological characteristics of this literature. Medical and social science journals were searched using Medline and PsychInfo. Studies were included if they tested the relationship between sexual orientation and adolescent substance use. Eighteen published studies were identified. Data analysis procedures followed expert guidelines, and used National Institutes of Health (NIH)-sponsored meta-analysis software. LGB adolescents reported higher rates of substance use compared to heterosexual youth (overall odds ratio = 2.89, Cohen's d = 0.59). Effect sizes varied by gender, bisexuality status, sexual orientation definition and recruitment source. None of the studies tested mediation and only one tested moderation. One employed a matched comparison group design, one used a longitudinal design, and very few controlled for possible confounding variables. The odds of substance use for LGB youth were, on average, 190% higher than for heterosexual youth and substantially higher within some subpopulations of LGB youth (340% higher for bisexual youth, 400% higher for females). Causal mechanisms, protective factors and alternative explanations for this effect, as well as long-term substance use outcomes in LGB youth, remain largely unknown.
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                Author and article information

                Contributors
                Brian Mustanski:
                Department of Medical Social SciencesFeinberg School of MedicineInstitute for Sexual and Gender Minority Health and WellbeingNorthwestern University625 N. Michigan Ave.Suite 2700Chicago, IL, 60611United States1 312 503 54211 312 503 4800brian@northwestern.edu
                ORCID: http://orcid.org/0000-0001-9222-5116
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: January 2017
                Publication date (Electronic): 7 January 2017
                Volume: 6
                Issue: 1
                Electronic Location Identifier: e1
                Affiliations
                [1] 1Department of Medical Social Sciences Feinberg School of Medicine Northwestern University Chicago, ILUnited States
                [2] 2Institute for Sexual and Gender Minority Health and Wellbeing Northwestern University Chicago, ILUnited States
                [3] 3Center for HIV Educational Studies and Training Hunter College, City University of New York New York, NYUnited States
                [4] 4Graduate Center of the City University New York, NYUnited States
                [5] 5Department of Biostatistics and Computational Biology University of Rochester Rochester, NYUnited States
                [6] 6Department of Epidemiology Emory University Atlanta, GAUnited States
                Author notes
                Corresponding Author: Brian Mustanski brian@ 123456northwestern.edu
                Author information
                http://orcid.org/0000-0001-9222-5116
                http://orcid.org/0000-0002-3574-8006
                http://orcid.org/0000-0002-4620-5840
                http://orcid.org/0000-0002-6875-7566
                http://orcid.org/0000-0001-5665-8598
                http://orcid.org/0000-0002-7728-0587
                http://orcid.org/0000-0002-7732-6557
                http://orcid.org/0000-0002-2325-0956
                Article
                Publisher ID: v6i1e1
                DOI: 10.2196/resprot.5740
                PMC ID: 5251167
                PubMed ID: 28062389
                SO-VID: 04aa4eea-b5d1-4f22-9e3d-776c3e8f36d1
                Copyright © ©Brian Mustanski, Krystal Madkins, George J Greene, Jeffrey T Parsons, Brent A Johnson, Patrick Sullivan, Michael Bass, Rebekah Abel. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.01.2017.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 12 August 2016
                Date revision requested : 15 September 2016
                Date revision received : 26 October 2016
                Date accepted : 23 November 2016
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: ehealth,hiv prevention,internet,risk reduction behavior,sexual behavior,sexually transmitted infections,young msm
                Data availability:
                Keywords: ehealth, hiv prevention, internet, risk reduction behavior, sexual behavior, sexually transmitted infections, young msm

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