Biomedical and Behavioral Outcomes of Keep It Up!: An eHealth HIV Prevention Program RCT

Abstract

Introduction: HIV diagnoses among young men who have sex with men are increasing, but few effective HIV prevention interventions exist for this population. An RCT was conducted of the online Keep It Up! intervention to determine if it significantly reduced condomless anal sex and sexually transmitted infections compared with an HIV knowledge condition.

Study design: From May 2013 to March 2017, a total of 901 participants were enrolled in a double-blinded RCT of Keep It Up! with 1-year follow-up. After completing baseline surveys and sexually transmitted infection testing, participants were randomized by an eHealth platform to the intervention or control condition.

Setting/participants: HIV-negative men who have sex with men reporting condomless anal sex, aged 18-29 years, were recruited through advertising and from HIV testing sites and outreach in Atlanta, Georgia; Chicago, Illinois; and New York, New York.

Intervention: Multimedia was used to address HIV knowledge and motivate safer behaviors. The control condition reflected existing online HIV information.

Main outcome measures: Primary outcomes were incident gonorrhea or chlamydia at 12-month follow-up and self-reported condomless anal sex with casual partners at 3-, 6-, and 12-month follow-up.

Results: In 2017, data were analyzed from 445 (49%) participants randomized to the intervention and 456 (51%) to the control. Participants were primarily racial/ethnic minorities (63%). Sexually transmitted infections at Month 12 was 40% lower for intervention participants (risk ratio=0.60, 95% CI=0.38, 0.95, p=0.01). For the primary behavioral outcome, both arms showed reductions over time with 44% of control and 37% of intervention participants reporting condomless anal sex at Month 12 (prevalence ratio=0.83, 95% CI=0.70, 0.99, p=0.04).

Conclusions: The Keep It Up! intervention resulted in significantly lower sexually transmitted infection incidence and a small but significant decrease in condomless anal sex 12 months post-intervention relative to an online HIV knowledge condition. In addition, this study demonstrated the feasibility and acceptability of at-home sexually transmitted infection testing as part of an eHealth intervention.

Trial registration: This study is registered at www.clinicaltrials.gov NCT01836445.

Appendix Figure 1.. Mean number of condomless anal sex acts, casual male partners, previous 3 months, 2013–2015.

Note: Points represent model-based estimated means; bars represent estimated 95% CIs for the means.

Appendix Figure 2.. Mean number of condomless anal sex partners, previous 3 months, 2013–2015.

Note: Points represent model-based estimated means; bars represent estimated 95% CIs for the means.

Figure 1.

Participant flow in the Keep It Up! RCT, 2013–2015. ^aOf those who met exclusion criteria, 812 participants met one criteria, 202 met two criteria, 36 met three criteria, and five met four criteria for exclusion. ^bAt Baseline, all 901 enrolled participants completed the survey but only 896 completed STI testing. Of the five who did not complete testing, three are in the control group and two are in the treatment group. ^cAt 12-month, 47 participants completed the 12-month survey but did not do STI testing. Of these participants, 21 in the treatment group and 26 in the control group. ^dAt 12-month, 25 participants completed STI testing but did not complete the survey. Of these participants, 13 were in the treatment group and 12 in the control group. KIU!, Keep It Up!; STI, Sexually Transmitted Infection;

Figure 2.. Participants reporting condomless anal sex with a casual male partner, previous 3 months, 2013–2015.

Note: Points represent model-based estimates; bars represent estimated 95% CIs.