Online Network Intervention to Increase HIV Pre-exposure Prophylaxis Intention

September 29, 2021 updated by: University of California, Davis

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • UC Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1707085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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