Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Aug 15;87(5):1128-1135.
doi: 10.1097/QAI.0000000000002711.

Using Novel Approaches to Evaluate Behavioral Interventions: Overlooked Significant HIV Prevention Effects in the HPTN 015 Project EXPLORE

Eileen V Pitpitan  1   2 , David P MacKinnon  3 , Lisa A Eaton  4 , Laramie R Smith  2 , Jennifer Wagman  5 , Thomas L Patterson  2
Affiliations
Randomized Controlled Trial

Using Novel Approaches to Evaluate Behavioral Interventions: Overlooked Significant HIV Prevention Effects in the HPTN 015 Project EXPLORE

Eileen V Pitpitan et al. J Acquir Immune Defic Syndr. .

Abstract

Background: Mediated and moderated processes that lead to intervention efficacy may underlie results of trials ruled as nonefficacious. The overall purpose of this study was to examine such processes to explain the findings of one of the largest, rigorously conducted behavioral intervention randomized controlled trials, EXPLORE.

Methods: Four thousand two hundred ninety-five HIV-negative men who have sex with men (MSM) in the United States were randomized in a 2-armed trial. Participants completed follow-up and an HIV test every 6 months up to 48 months. We used multiple and causal mediation analyses to test 5 mediators, including safer sex self-efficacy and condomless receptive anal sex with HIV-positive or status-unknown partners on our primary outcome (HIV seroconversion). We also examined whether intervention effects on the mediators would be moderated by robust correlates of HIV among MSM, including stimulant use.

Results: There were significant effects of the intervention on all hypothesized mediators. Stimulant use moderated the effect on condomless receptive anal sex In stratified multiple mediation models, we found that among MSM with low stimulant use, the intervention significantly prevented HIV by reducing condomless receptive anal sex with HIV-positive or status-unknown partners. Among MSM with higher stimulant use, there were no indirect effects of the intervention on HIV through any of the hypothesized mediators.

Conclusion: The results suggest that the null effect found in the original EXPLORE trial might have occurred as a function of previously unexplored mediated and moderated processes. This study illustrates the value of testing mediated and moderated pathways in randomized trials, even in trials ruled out as nonefficacious.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.. Multiple mediator model results among MSM with low stimulant use (n= 2,749)
**p < .01; ***p < .001
Figure 2.
Figure 2.. Multiple mediator model results among MSM with higher stimulant use (n= 885)
*p < .05; ***p < .001
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Noar SM. Behavioral Interventions to Reduce HIV-related Sexual Risk Behavior: Review and Synthesis of Meta-Analytic Evidence. AIDS Behav. 2007;12(3):335–353. doi:10.1007/s10461-007-9313-9 - DOI - PubMed
    1. Lyles CM, Kay LS, Crepaz N, et al. Best-Evidence Interventions: Findings From a Systematic Review of HIV Behavioral Interventions for US Populations at High Risk, 2000–2004. Am J Public Health. 2007;97(1):133–143. doi:10.2105/AJPH.2005.076182 - DOI - PMC - PubMed
    1. Fishbein M, Pequegnat W. Evaluating AIDS prevention interventions using behavioral and biological outcome measures. Sex Transm Dis. 2000;27(2):101–110. - PubMed
    1. MacKinnon DP. Analysis of mediating variables in prevention and intervention research. NIDA research monograph. 1994;139:127–127. - PubMed
    1. JAMA Guide to Statistics and Methods ∣ JAMAevidence ∣ McGraw-Hill Medical. Accessed August 10, 2020. https://jamaevidence.mhmedical.com/book.aspx?bookid=2742

Publication types

Substances