- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04771312
Online Network Intervention to Increase HIV Pre-exposure Prophylaxis Intention
Online Network Intervention to Increase HIV Pre-exposure Prophylaxis Intention: A Mobile App-based Experiment
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Davis, California, United States, 95616
- UC Davis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Information-only intervention
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.
|
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.
|
Experimental: Social support network intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline on Intention to start PrEP
Time Frame: Baseline and 1 week
|
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
Time Frame: Baseline and 1 week
|
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
Time Frame: Baseline and 1 week
|
4-items on functional knowledge of HIV pre-exposure prophylaxis.
Options include "True," "False," and "Unsure."
|
Baseline and 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Social Support
Time Frame: 1 week
|
Validated measure of perceived informational and emotional support from 1 = "strongly disagree" to 5 = "strongly agree."
|
1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1707085
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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