Behavior, HealthNCT04771312
Online Network Intervention to Increase HIV Pre-exposure Prophylaxis Intention
A study testing Mobile app information-only intervention and Mobile app social support network intervention in people with Behavior, Health, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Behavior, Health
- What is being tested?
- Mobile app information-only intervention and Mobile app social support network intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gay or bisexual male
- Aged 18 and 35
- HIV-negative
- Not on PrEP
- Using an Android smartphone
Who cannot join
- Already participating in another HIV-related study.
- Not able or willing to carry an Android smartphone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Behavior, Health
- Being tested
- Mobile app information-only intervention, Mobile app social support network intervention
- Keywords
- PrEP, HIV prevention
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile app information-only interventionBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mobile app social support network intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: 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."
Measured: Baseline and 1 week
Secondary outcomes (1)
Perceived Social Support
Validated measure of perceived informational and emotional support from 1 = "strongly disagree" to 5 = "strongly agree."
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start19 Jul 2021
- Primary completion8 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771312
- Sponsor's protocol ID
- 1707085
- Status last verified
- Sep 2021
- First submitted
- 22 Feb 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Network Intervention to Increase HIV Pre-exposure Prophylaxis Intention: A Mobile App-based Experiment
- ClinicalTrials.gov ID
- NCT04771312
- Acronym / sponsor ID
- 1707085
- Conditions
- Behavior, Health
- Keywords
- PrEP, HIV prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information-only intervention | Active comparator | Behavioral: Mobile app information-only interventionParticipants 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. |
| Social support network intervention | Experimental | Behavioral: Mobile app social support network interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gay or bisexual male
- Aged 18 and 35
- HIV-negative
- Not on PrEP
- Using an Android smartphone
Key exclusion criteria (2 listed)
- Already participating in another HIV-related study.
- Not able or willing to carry an Android smartphone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile app information-only interventionMobile 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. | Behavioural | Information-only intervention |
| Mobile app social support network interventionMobile 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. | Behavioural | Social support network intervention |
Primary outcome
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."
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."
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."
1 secondary outcome
Perceived Social Support
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app information-only intervention and Mobile app social support network intervention in people with Behavior, Health, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on Intention to start PrEP (time frame: Baseline and 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.