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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04771312
Other study ID # 1707085
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 19, 2021
Est. completion date September 15, 2021

Study information

Verified date September 2021
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Roughly 1.7 million people worldwide are infected with HIV each year (UNAIDS, 2017). HIV pre-exposure prophylaxis (or PrEP) refers to taking a daily oral medicine to reduce the risk of contracting HIV. Known by the brand name Truvada or Descovy, 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. In particular, online networks can provide anonymous support that transcends geographical boundaries (DeAndrea, 2015). Stigmatized behaviors, such as the adoption of PrEP, may greatly benefit from interventions that utilize online networks. This project examines how online networks can influence PrEP adoption intentions among gay and bisexual men through a mobile app-based experiment. There are several ways in which online networks may influence health; however, social support may serve as the primary mechanism that influences PrEP adoption. In the context of HIV prevention, social support has generally reduced HIV-related risky behaviors (Qiao, Li, & Stanton, 2014). Thus, it is important to consider social support as a factor than can influence one's intention to adopt PrEP. This field experiment will randomly assign participants into a social support condition or information-only control, and then randomly assign them into homophilous, clustered six-member peer networks. Both conditions will involve an information component consisting messages aimed to address awareness, knowledge, and perceived barriers of PrEP adoption. Social support will be operationalized through an online chatting tool where participants 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 15, 2021
Est. primary completion date September 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Gay or bisexual male - Aged 18 and 35 - HIV-negative - Not on PrEP - Using an Android smartphone Exclusion Criteria: - Already participating in another HIV-related study. - Not able or willing to carry an Android smartphone.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mobile app information-only intervention
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.
Mobile app social support network intervention
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.

Locations

Country Name City State
United States UC Davis Davis California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Perceived Social Support Validated measure of perceived informational and emotional support from 1 = "strongly disagree" to 5 = "strongly agree." 1 week
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