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NCT03167606

A Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Diverse Adolescent MSM

Completed NA Results posted Last updated 23 February 2023
What this trial tests

NA trial testing MyPEEPS Mobile in HIV Infections in 764 participants. Completed in 13 May 2021.

Timeline
1 June 2018
Primary endpoint
13 May 2021
13 May 2021

Quick facts

Lead sponsorColumbia University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment764
Start date1 June 2018
Primary completion13 May 2021
Estimated completion13 May 2021
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Columbia University

Who can join

Adults 13 to 18, male only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Condomless Anal Sex Acts Primary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

The number of condomless anal sex acts (CASA) will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which condoms were not used.

Baseline
GroupValue95% CI
Immediate Intervention1.53± 0.29
Delayed Intervention1.45± 0.27
3-Month Follow-up
GroupValue95% CI
Immediate Intervention1.04± 0.26
Delayed Intervention1.63± 0.38
6-Month Follow-up
GroupValue95% CI
Immediate Intervention1.68± 0.47
Delayed Intervention1.21± 0.25
9-Month Follow-up
GroupValue95% CI
Immediate Intervention1.70± 0.36
Delayed Intervention1.65± 0.33
12-Month Follow-up
GroupValue95% CI
Delayed Intervention1.47± 0.36
Number of Anal Sex Partners Primary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

The number of anal sex partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners in the past 3 months at each of the follow-up timepoints.

Baseline
GroupValue95% CI
Immediate Intervention0.95± 0.11
Delayed Intervention0.87± 0.09
3-Month Follow-up
GroupValue95% CI
Immediate Intervention0.86± 0.13
Delayed Intervention0.71± 0.09
6-Month Follow-up
GroupValue95% CI
Immediate Intervention0.90± 0.11
Delayed Intervention0.84± 0.10
9-Month Follow-up
GroupValue95% CI
Immediate Intervention1.00± 0.13
Delayed Intervention0.77± 0.08
12-Month Follow-up
GroupValue95% CI
Delayed Intervention1.27± 0.21
Number of Condomless Anal Sex Partners Primary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

The number of condomless anal sex (CAS) partners will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Participants are asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in their lifetime at the baseline timepoint and then asked to report the number of insertive and receptive anal sex partners with whom condoms were not used in the past 3 months at each of the follow-up timepoints.

Baseline
GroupValue95% CI
Immediate Intervention0.53± 0.08
Delayed Intervention0.42± 0.05
3-Month Follow-up
GroupValue95% CI
Immediate Intervention0.50± 0.08
Delayed Intervention0.38± 0.06
6-Month Follow-up
GroupValue95% CI
Immediate Intervention0.43± 0.06
Delayed Intervention0.47± 0.06
9-Month Follow-up
GroupValue95% CI
Immediate Intervention0.63± 0.11
Delayed Intervention0.40± 0.05
12-Month Follow-up
GroupValue95% CI
Delayed Intervention0.72± 0.17
Number of Anal Sex Acts Under the Influence of Drugs/Alcohol Primary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

The number of anal sex acts under the influence of drugs/alcohol will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. At each timepoint, participants were asked to report the past 3 month number of insertive and receptive anal sex acts during which they had been drinking alcohol or using drugs.

Baseline
GroupValue95% CI
Immediate Intervention0.33± 0.09
Delayed Intervention0.45± 0.11
3-Month Follow-up
GroupValue95% CI
Immediate Intervention0.35± 0.16
Delayed Intervention0.42± 0.14
6-Month Follow-up
GroupValue95% CI
Immediate Intervention0.35± 0.18
Delayed Intervention0.43± 0.09
9-Month Follow-up
GroupValue95% CI
Immediate Intervention0.41± 0.11
Delayed Intervention0.54± 0.12
12-Month Follow-up
GroupValue95% CI
Delayed Intervention0.53± 0.16
Number of Participants With Self-reported Pre-exposure Prophylaxis (PrEP) Use Primary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

Participants were asked if they have ever used Pre-exposure Prophylaxis (PrEP) at baseline, if they have used PrEP in the prior 3 months at all timepoints, and if they are currently using PrEP at the time of study visit at all timepoints.

Baseline
GroupValue95% CI
Immediate Intervention10
Delayed Intervention10
3-Month Follow-up
GroupValue95% CI
Immediate Intervention14
Delayed Intervention14
6-Month Follow-up
GroupValue95% CI
Immediate Intervention20
Delayed Intervention16
9-Month Follow-up
GroupValue95% CI
Immediate Intervention13
Delayed Intervention14
12-Month Follow-up
GroupValue95% CI
Delayed Intervention25
Number of Participants With Self-reported Non-occupational Post-Exposure Prophylaxis (nPEP) Use Primary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

Participants were asked if they've ever used Non-occupational Post-Exposure Prophylaxis (nPEP) at baseline and if they've used nPEP in the 3 months prior to each study visit timepoint.

Baseline
GroupValue95% CI
Immediate Intervention4
Delayed Intervention6
3-Month Follow-up
GroupValue95% CI
Immediate Intervention3
Delayed Intervention4
6-Month Follow-up
GroupValue95% CI
Immediate Intervention5
Delayed Intervention8
9-Month Follow-up
GroupValue95% CI
Immediate Intervention1
Delayed Intervention3
12-Month Follow-up
GroupValue95% CI
Delayed Intervention3
Number of Participants With Self-Reported HIV Testing Primary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

Participants were asked to report how many times they've ever been tested for HIV at baseline and at each follow-up timepoint they were asked how many times they've tested for HIV in the prior 3 months.

Baseline
GroupValue95% CI
Immediate Intervention63
Delayed Intervention55
3-Month Follow-up
GroupValue95% CI
Immediate Intervention90
Delayed Intervention79
6-Month Follow-up
GroupValue95% CI
Immediate Intervention84
Delayed Intervention69
9-Month Follow-up
GroupValue95% CI
Immediate Intervention93
Delayed Intervention69
12-Month Follow-up
GroupValue95% CI
Delayed Intervention71
Number of Participants With Self-Reported Sexually Transmitted Infection (STI) Testing Primary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

Participants were asked to report past 3-month testing for sexually transmitted infections (STIs) at each timepoint.

Baseline
GroupValue95% CI
Immediate Intervention73
Delayed Intervention65
3-Month Follow-up
GroupValue95% CI
Immediate Intervention63
Delayed Intervention49
6-Month Follow-up
GroupValue95% CI
Immediate Intervention56
Delayed Intervention44
9-Month Follow-up
GroupValue95% CI
Immediate Intervention59
Delayed Intervention44
12-Month Follow-up
GroupValue95% CI
Delayed Intervention53
Intent to Have Anal Sex Secondary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

Participants were presented with the statement "During the next 3 months, I am not planning to have anal sex" with response options ranging from 1=Very true to 4=Very untrue. The mean value was calculated per group and per timepoint.

Baseline
GroupValue95% CI
Immediate Intervention2.35± 0.06
Delayed Intervention2.40± 0.05
3-Month Follow-up
GroupValue95% CI
Immediate Intervention2.30± 0.06
Delayed Intervention2.36± 0.06
6-Month Follow-up
GroupValue95% CI
Immediate Intervention2.33± 0.06
Delayed Intervention2.35± 0.06
9-Month Follow-up
GroupValue95% CI
Immediate Intervention2.42± 0.06
Delayed Intervention2.40± 0.06
12-Month Follow-up
GroupValue95% CI
Delayed Intervention2.42± 0.06
Intent to Always Use Condoms During Anal Sex With All Sex Partners Secondary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

Participants responded to the statement "During the next 3 months, I plan to always use condoms during anal sex with all of my sex partners" with response options ranging from 1=Very true to 4=Very untrue. Mean values were calculated by group for each timepoint.

Baseline
GroupValue95% CI
Immediate Intervention3.38± 0.04
Delayed Intervention3.41± 0.04
3-Month Follow-up
GroupValue95% CI
Immediate Intervention3.45± 0.05
Delayed Intervention3.44± 0.04
6-Month Follow-up
GroupValue95% CI
Immediate Intervention3.34± 0.05
Delayed Intervention3.37± 0.05
9-Month Follow-up
GroupValue95% CI
Immediate Intervention3.42± 0.05
Delayed Intervention3.38± 0.04
12-Month Follow-up
GroupValue95% CI
Delayed Intervention3.35± 0.05
Intent to Use PrEP as a Strategy to Reduce HIV Infection Risk Secondary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

Participants responded to the statement "I plan to use PrEP as a strategy to reduce my risk for HIV infection during the next three months" with response values ranging from 1=Very true to 4=Very untrue. Mean values were calculated for each group at each timepoint.

Baseline
GroupValue95% CI
Immediate Intervention2.67± 0.06
Delayed Intervention2.65± 0.05
3-Month Follow-up
GroupValue95% CI
Immediate Intervention2.82± 0.06
Delayed Intervention2.66± 0.06
6-Month Follow-up
GroupValue95% CI
Immediate Intervention2.79± 0.06
Delayed Intervention2.66± 0.06
9-Month Follow-up
GroupValue95% CI
Immediate Intervention2.74± 0.06
Delayed Intervention2.59± 0.05
12-Month Follow-up
GroupValue95% CI
Delayed Intervention2.83± 0.06
Self-efficacy for Safer Sex and Situational Temptation for Unsafe Sex Secondary · Baseline, 3, 6, and 9 months (Intervention group); Baseline, 3, 6, 9, and 12 months (Delayed Intervention group)

Participants were asked to respond to 10 questions assessing self-efficacy in practicing condom use and safer sex communication with a partner. A sample item is "if I didn't want to have sex with my partner, I would be able to say no." Response options ranged from 1=Strongly agree to 4=Strongly disagree. Question scores ranged 1-4, values averaged and total scores ranged from 1 to 4, with lower values indicating higher self-efficacy

Baseline
GroupValue95% CI
Immediate Intervention1.51± 0.02
Delayed Intervention1.52± 0.02
3-Month Follow-up
GroupValue95% CI
Immediate Intervention1.44± 0.02
Delayed Intervention1.54± 0.02
6-Month Follow-up
GroupValue95% CI
Immediate Intervention1.50± 0.02
Delayed Intervention1.52± 0.02
9-Month Follow-up
GroupValue95% CI
Immediate Intervention1.47± 0.02
Delayed Intervention1.55± 0.02
12-Month Follow-up
GroupValue95% CI
Delayed Intervention1.44± 0.02

Sponsor's own description

The proposed MyPEEPS Mobile intervention is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information specifically developed for at-risk young men who have sex with men (YMSM). This will be the one of the first studies to test the efficacy of a scaled-up, mobile version of an existing human immunodeficiency virus (HIV) prevention intervention originally developed for, designed by, and piloted for, a diverse group of YMSM. MyPEEPS Mobile will be tested in an randomized controlled trial with racially and ethnically diverse HIV-negative or unknown status YMSM aged 13-18 at four geographically diverse sites: Birmingham, Chicago, New York City, and Seattle, allowing for increased generalizability of findings.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy of MyPEEPS Mobile, an HIV Prevention Intervention Using Mobile Technology, on Reducing Sexual Risk Among Same-Sex Attracted Adolescent Males: A Randomized Clinical Trial.
    Schnall R, Kuhns LM, Pearson C, Batey DS, et al · · 2022 · cited 33× · PMID 36129712 · DOI 10.1001/jamanetworkopen.2022.31853
  2. A randomized controlled efficacy trial of an mHealth HIV prevention intervention for sexual minority young men: MyPEEPS mobile study protocol.
    Kuhns LM, Garofalo R, Hidalgo M, Hirshfield S, et al · · 2020 · cited 30× · PMID 31941475 · DOI 10.1186/s12889-020-8180-4
  3. A Qualitative Study to Inform Adaptation of MyPEEPS Mobile for Transmasculine Youth.
    Anderson A, Karczmar A, Kuhns LM, Garofalo R, et al · · 2022 · cited 7× · PMID 35153221 · DOI 10.1353/hpu.2022.0022
  4. Examining the Information Systems Success (ISS) of a mobile sexual health app (MyPEEPS Mobile) from the perspective of very young men who have sex with men (YMSM).
    Cordoba E, Idnay B, Garofalo R, Kuhns LM, et al · · 2021 · cited 7× · PMID 34385097 · DOI 10.1016/j.ijmedinf.2021.104529
  5. Are State-Level HIV Testing Policies for Minors Associated With HIV Testing Behavior and Awareness of Home-Based HIV Testing in Young Men Who Have Sex With Men?
    Cordoba E, Kuizon CM, Garofalo R, Kuhns LM, et al · · 2022 · cited 6× · PMID 35241362 · DOI 10.1016/j.jadohealth.2021.12.023
  6. Homonegative Victimization and Perceived Stress among Adolescent Sexual Minority Males: The Attenuating Role of Peer and Family Support.
    Gordián-Arroyo A, Schnall R, Garofalo R, Kuhns LM, et al · · 2022 · cited 5× · PMID 36776753 · DOI 10.1080/19317611.2022.2124341
  7. Predictors of Past-Year Health Care Utilization Among Young Men Who Have Sex with Men Using Andersen's Behavioral Model of Health Service Use.
    Diaz JE, Sandh S, Schnall R, Garofalo R, et al · · 2022 · cited 4× · PMID 35867076 · DOI 10.1089/lgbt.2021.0488
  8. Social Marketing Perspective on Participant Recruitment in Informatics-Based Intervention Studies.
    Idnay B, Cordoba E, Ramirez SO, Xiao E, et al · · 2024 · cited 1× · PMID 38703337 · DOI 10.1007/s10461-024-04355-6

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