NCT04771312

Brief Summary

HIV pre-exposure prophylaxis (or PrEP) is an effective additional preventative measure for reducing the risk of HIV transmission. To address low levels of uptake, there is a need for public health interventions to increase target populations' awareness and willingness for adopting PrEP. One potential solution may be to incorporate a network intervention, which utilizes the connections between individuals to facilitate health behavior. This project examines how online networks can influence PrEP adoption intentions among gay and bisexual men through a mobile app-based experiment. In this study, participants will be randomly assigned into a social support condition or information-only control. Both conditions will involve an information component consisting messages aimed to address awareness, knowledge, and perceived barriers of PrEP adoption. However, those in the social support condition will also have an online chatting tool where they can discuss topics surrounding PrEP. The primary objective of this study is to test the effectiveness of the mobile app intervention in increasing participants' knowledge/attitudes/intentions to initiate PrEP. The secondary objective of this study is to determine the mechanism of the intervention through mediation analyses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 19, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

February 22, 2021

Last Update Submit

September 29, 2021

Conditions

Behavior, Health

Keywords

PrEPHIV prevention

Outcome Measures

Primary Outcomes (3)

  • Change from baseline on Intention to start PrEP

    3-item measure based on the Reasoned Action Approach for intention to start PrEP from 1 = "strongly disagree" to 5 = "strongly agree."

    Baseline and 1 week

  • Change from baseline on Attitude toward starting PrEP

    7-point semantic differential measure based on the Reasoned Action Approach for attitude to start PrEP with items such as "Good/Bad" and "Useful/Useless."

    Baseline and 1 week

  • Change from baseline on Knowledge of PrEP

    4-items on functional knowledge of HIV pre-exposure prophylaxis. Options include "True," "False," and "Unsure."

    Baseline and 1 week

Secondary Outcomes (1)

  • Perceived Social Support

    1 week

Study Arms (2)

Information-only intervention

ACTIVE COMPARATOR

Participants are randomly assigned to 6-person peer networks in a mobile app. Participants in the information-only condition could respond to daily questions in a diary.

Behavioral: Mobile app information-only intervention

Social support network intervention

EXPERIMENTAL

Participants are randomly assigned to 6-person peer networks in a mobile app. Participants in the social support condition could use an online chatting tool where they can send messages to their own network.

Behavioral: Mobile app social support network intervention

Interventions

Mobile app information-only interventionBEHAVIORAL

Mobile app intervention. Participants view information regarding PrEP that address beliefs and barriers surrounding adoption and uptake. Participants can respond to daily questions in a diary. Participants can also use a locator tool to find where PrEP can be found near them.

Information-only intervention
Mobile app social support network interventionBEHAVIORAL

Mobile app intervention. Participants view information regarding PrEP that address beliefs and barriers surrounding adoption and uptake. Participants are shown an online chatting tool where they can discuss with each other and answer daily questions. Participants can also use a locator tool to find where PrEP can be found near them.

Social support network intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMust identify as male and be assigned male at birth.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gay or bisexual male
  • Aged 18 and 35
  • HIV-negative
  • Not on PrEP
  • Using an Android smartphone

You may not qualify if:

  • Already participating in another HIV-related study.
  • Not able or willing to carry an Android smartphone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

July 19, 2021

Primary Completion

September 8, 2021

Study Completion

September 15, 2021

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers.

Locations

US(1)