HIV InfectionsCombineAppNCT06205368
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
A study testing Combine mobile app, Motivational interview and HIV/STI testing in people with HIV Infections and STI, run by Emory University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the efficacy of a mobile app, Combine, to increase the uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP) over 24 months and to assess the effects of different implementation strategies on intervention maintenance among GBMSM in rural southern United States. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, STI, HIV Pre-exposure Prophylaxis
- What is being tested?
- Combine mobile app, Motivational interview and HIV/STI testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Assigned male at birth and currently identifies as male
- Age 18-45 years, inclusive
- Reside in the U.S. South as defined by the Census Bureau or in Missouri
- Reside in a county classified as rural using the Index of Relative Rurality
- Have an Android or iPhone operating system (iOS) phone with active service
- Willing to download a study app to their phone
Show all 10Show fewer
- English speaker
- Report anal sex with a man in the past 12 months
- HIV-negative or unknown serostatus
- Not currently using PrEP
Who cannot join
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of a Mobile HIV Prevention Application to Increase HIV and STI Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
The goal of this clinical trial is to test the efficacy of a mobile app, Combine, to increase the uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP) over 24 months and to assess the effects of different implementation strategies on intervention maintenance among GBMSM in rural southern United States. The main aims of the study are:
- To assess the relative effects of three treatment conditions on gains in engagement in HIV prevention compared to a modified standard of care control condition
- Measure and assess secondary factors affecting app implementation
- Refine implementation strategies and coordinate with potential funders Participants will download an HIV prevention smartphone app and be randomly assigned to one of four groups:
- Control: App access only
- Self-testing: App access + ability to order HIV and STI self-test kits
- Motivational interview: App access + motivational interview to develop plans to use app effectively.
- Self-testing + motivational interview: App access + ability to order HIV and STI self-test kits + motivational interview to develop plans to use app effectively.
Researchers will compare each of the latter three groups to the control condition to see if HIV and STI testing increase in these groups
Read the detailed description
The uptake of HIV and STI testing among gay and bisexual men who have sex with men (GBMSM) in the rural southern US is low. However, HIV and STI testing is a fundamental gateway to preventive services, such as PrEP, and treatment provision. Thus, the research team must identify methods to increase the uptake of HIV and STI testing among this population that experiences disproportionate HIV and STI incidence. The research team has developed an app, Combine, that is an adaptation of HealthMindr, an app that has demonstrated efficacy in increasing the uptake of HIV testing among urban GBMSM. Combine was adapted using input from GBMSM in rural areas to address issues specific to this population such as increased experiences of stigma and reduced access to culturally competent care. The investigator proposes to conduct a Type 2 Hybrid Effectiveness-Implementation randomized controlled trial to test the efficacy of Combine to increase uptake of HIV and STI testing over 24 months of follow-up and to examine the effect of different implementation strategies among GBMSM in the rural South. Combine will include components for self-administered risk assessments, developing and supporting a plan for frequent HIV and STI testing, information about PrEP, and PrEP and HIV/STI testing provider locators. Previous trials of app-based HIV prevention have included the ability to order free HIV and STI self-test kits. However, there is no consensus among health officials around whether at-home self-tests are an optimal solution for increasing HIV and STI testing. Additionally, despite the availability of free HIV and STI self-test kits in previous studies, large proportions of men still do not complete HIV tests, and even fewer complete STI tests. Thus, the investigator will evaluate the effect of two different intervention components on HIV and STI uptake in a 2x2 factorial trial design: availability of HIV and STI self-test kits ordered through the app and a motivational interview designed to enhance the existing app content, increased self-efficacy to develop and follow through with a testing plan, and develop strategies to deal with experiences of stigma.
The investigator will assess the main effects of the availability of HIV and STI self-test kits and the motivational interview on HIV and STI testing uptake, PrEP initiation, and intervention maintenance over 24 months of follow-up. The investigator's community-based partner, Engaging Arkansas Communities, will work with the research team through all stages of the project to ensure that the team is obtaining the necessary data to inform future implementation.
- Conditions
- HIV Infections, STI, HIV Pre-exposure Prophylaxis
- Being tested
- Combine mobile app, Motivational interview, HIV/STI testing
- Keywords
- GBMSM, PrEP, HIV, Gay, HIV prevention, STI testing, HIV testing
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combine mobile appBehavioural
Also called Mobile app
- HIV/STI testing: learn more about testing options; create a plan to test 1-4 times in the coming year; locate places for those tests and/or order at-home test kits; and schedule reminders for periodic testing
- Pre-exposure prophylaxis: PrEP self-assessment at first app use; monthly rescreening for PrEP eligibility; recommendation for PrEP based on Centers for Disease Control and Prevention (CDC) criteria; PrEP provider locator.
- Behavioral risk assessment: e.g. HIV risk behaviors; sex while drunk or high, condomless anal intercourse with a positive or unknown HIV status partner, multiple sex partners, recent STI diagnosis, use of drugs) and protective behaviors
- Non-occupational post-exposure prophylaxis (nPEP): information about nPEP; self-assessment; locator; referral to PrEP for men who evaluate multiple exposures for nPEP indication
- Product ordering: participants can order condoms, condom-compatible lubricants, and at-home STI specimen collection kits.
Motivational interviewBehavioural
The interview will be grounded in the Social Cognitive Theory of self-regulation (SCT) to reflect the underlying theory of the Combine app. It will be designed to enhance the effectiveness of the app by highlighting app features (e.g., frequently asked questions, product ordering, testing locators) and discussing strategies for following through on goals related to sexual health (e.g., creating and adhering to a testing plan)
HIV/STI testingBehavioural
Participants will be able to order free HIV/STI self-test kits; they will be able to order up to two sets of kits during each of years 1 and 2 of follow-up. HIV and STI test kit orders are independent: ordering an HIV test kit does not trigger shipment of an STI kit and vice versa. When an order is placed, kits containing biospecimen self-collection tools are shipped directly to the participant along with written instructions and a link to video instructions on how to collect each of the samples (e.g., urine, rectal, blood). Return packaging is enclosed with instructions for participants to locate a drop-off location to return their samples to the lab.
| Study group | Role | What they receive |
|---|---|---|
| Combine app with all features except the ability to order self-test kits | Other | Participants will receive a modified standard of care which consists of the Combine app with all features except the ability to order self-test kits. The HIV/STI testing locator in the app will be available. Receives: Behavioral: Combine mobile app |
| Combine app + motivational interview | Other | In addition to the other Combine app features, participants will receive a motivational interview within 4 weeks of downloading the app. Receives: Behavioral: Combine mobile app; Behavioral: Motivational interview |
| Combine app + ability to order up 2 free HIV/STI self-test kits | Other | In addition to the other Combine app features, participants in this arm will be able to order up to two HIV/STI self-test kits at no charge during each year of follow-up. Receives: Behavioral: Combine mobile app; Behavioral: HIV/STI testing |
| Combine app + motivational interview + ability to order HIV/STI test kits via the app | Other | In addition to the other Combine app features, participants in this arm will receive both the motivational interview and the ability to order HIV/STI test kits via the app. Receives: Behavioral: Combine mobile app; Behavioral: Motivational interview; Behavioral: HIV/STI testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of HIV testing
The investigator will look at the change in number of participants getting tested for HIV by using online surveys. Uptake of testing will be defined as ordering, using, and returning a kit for laboratory analysis or obtaining a test at an in-person provider and reporting the result.
Measured: Screening, Month 6, Month 12, Month 18, Month 24
Uptake of STI testing
The investigator will look at the change in number of participants getting tested for STIs by using online surveys. Uptake of testing will be defined as ordering, using, and returning a kit for laboratory analysis or obtaining a test at an in-person provider and reporting the result.
Measured: Screening, Month 6, Month 12, Month 18, Month 24
PrEP initiation
The investigator will look at the change in number of participants taking PrEP over the course of the study. PrEP initiation will be defined as obtaining a new PrEP prescription for the first time or after a period of non-use of at least three months
Measured: Screening, Month 6, Month 12, Month 18, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start27 Mar 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jeb Jones, Emory University
- Investigators
- Jeb Jones, PhD, Principal investigator, Rollins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205368
- Sponsor's protocol ID
- STUDY00006280
- Other IDs
- R01MH134267-01
- Acronym
- CombineApp
- Status last verified
- Oct 2026
- First submitted
- 4 Jan 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographics and Primary Outcomes data will be shared upon request.
Publications
Jones J, Manley G, Glynn TR, Wall KM, Baral SD, Harris ED, Benkeser D, Sullivan PS. Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis Initiation Among Rural Men Who Have Sex With Men in the Southern United States: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 23;14:e69540. doi: 10.2196/69540.
PubMed 40699887
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Mobile HIV Prevention Application to Increase HIV and STI Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT06205368
- Acronym / sponsor ID
- CombineApp / STUDY00006280
- Conditions
- HIV Infections, STI, HIV Pre-exposure Prophylaxis
- Keywords
- GBMSM, PrEP, HIV, Gay, HIV prevention, STI testing, HIV testing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Jan 2024 (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.
The goal of this clinical trial is to test the efficacy of a mobile app, Combine, to increase the uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP) over 24 months and to assess the effects of different implementation strategies on intervention maintenance among GBMSM in rural southern United States. The main aims of the study are:
- To assess the relative effects of three treatment conditions on gains in engagement in HIV prevention compared to a modified standard of care control condition
- Measure and assess secondary factors affecting app implementation
- Refine implementation strategies and coordinate with potential funders Participants will download an HIV prevention smartphone app and be randomly assigned to one of four groups:
- Control: App access only
- Self-testing: App access + ability to order HIV and STI self-test kits
- Motivational interview: App access + motivational interview to develop plans to use app effectively.
- Self-testing + motivational interview: App access + ability to order HIV and STI self-test kits + motivational interview to develop plans to use app effectively.
Researchers will compare each of the latter three groups to the control condition to see if HIV and STI testing increase in these groups
Detailed description
The uptake of HIV and STI testing among gay and bisexual men who have sex with men (GBMSM) in the rural southern US is low. However, HIV and STI testing is a fundamental gateway to preventive services, such as PrEP, and treatment provision. Thus, the research team must identify methods to increase the uptake of HIV and STI testing among this population that experiences disproportionate HIV and STI incidence. The research team has developed an app, Combine, that is an adaptation of HealthMindr, an app that has demonstrated efficacy in increasing the uptake of HIV testing among urban GBMSM. Combine was adapted using input from GBMSM in rural areas to address issues specific to this population such as increased experiences of stigma and reduced access to culturally competent care. The investigator proposes to conduct a Type 2 Hybrid Effectiveness-Implementation randomized controlled trial to test the efficacy of Combine to increase uptake of HIV and STI testing over 24 months of follow-up and to examine the effect of different implementation strategies among GBMSM in the rural South. Combine will include components for self-administered risk assessments, developing and supporting a plan for frequent HIV and STI testing, information about PrEP, and PrEP and HIV/STI testing provider locators. Previous trials of app-based HIV prevention have included the ability to order free HIV and STI self-test kits. However, there is no consensus among health officials around whether at-home self-tests are an optimal solution for increasing HIV and STI testing. Additionally, despite the availability of free HIV and STI self-test kits in previous studies, large proportions of men still do not complete HIV tests, and even fewer complete STI tests. Thus, the investigator will evaluate the effect of two different intervention components on HIV and STI uptake in a 2x2 factorial trial design: availability of HIV and STI self-test kits ordered through the app and a motivational interview designed to enhance the existing app content, increased self-efficacy to develop and follow through with a testing plan, and develop strategies to deal with experiences of stigma.
The investigator will assess the main effects of the availability of HIV and STI self-test kits and the motivational interview on HIV and STI testing uptake, PrEP initiation, and intervention maintenance over 24 months of follow-up. The investigator's community-based partner, Engaging Arkansas Communities, will work with the research team through all stages of the project to ensure that the team is obtaining the necessary data to inform future implementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combine app with all features except the ability to order self-test kits | Other | Behavioral: Combine mobile appParticipants will receive a modified standard of care which consists of the Combine app with all features except the ability to order self-test kits. The HIV/STI testing locator in the app will be available. |
| Combine app + motivational interview | Other | Behavioral: Combine mobile app, Behavioral: Motivational interviewIn addition to the other Combine app features, participants will receive a motivational interview within 4 weeks of downloading the app. |
| Combine app + ability to order up 2 free HIV/STI self-test kits | Other | Behavioral: Combine mobile app, Behavioral: HIV/STI testingIn addition to the other Combine app features, participants in this arm will be able to order up to two HIV/STI self-test kits at no charge during each year of follow-up. |
| Combine app + motivational interview + ability to order HIV/STI test kits via the app | Other | Behavioral: Combine mobile app, Behavioral: Motivational interview, Behavioral: HIV/STI testingIn addition to the other Combine app features, participants in this arm will receive both the motivational interview and the ability to order HIV/STI test kits via the app. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Assigned male at birth and currently identifies as male
- Age 18-45 years, inclusive
- Reside in the U.S. South as defined by the Census Bureau or in Missouri
- Reside in a county classified as rural using the Index of Relative Rurality
- Have an Android or iPhone operating system (iOS) phone with active service
Key exclusion criteria (1 listed)
- Unable to provide consent
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 |
|---|---|---|
| Combine mobile appAlso: Mobile app* HIV/STI testing: learn more about testing options; create a plan to test 1-4 times in the coming year; locate places for those tests and/or order at-home test kits; and schedule reminders for periodic testing * Pre-exposure prophylaxis: PrEP self-assessment at first app use; monthly rescreening for PrEP eligibility; recommendation for PrEP based on Centers for Disease Control and Prevention (CDC) criteria; PrEP provider locator. * Behavioral risk assessment: e.g. HIV risk behaviors; sex while drunk or high, condomless anal intercourse with a positive or unknown HIV status partner, multiple sex partners, recent STI diagnosis, use of drugs) and protective behaviors * Non-occupational post-exposure prophylaxis (nPEP): information about nPEP; self-assessment; locator; referral to PrEP for men who evaluate multiple exposures for nPEP indication * Product ordering: participants can order condoms, condom-compatible lubricants, and at-home STI specimen collection kits. | Behavioural | Combine app + ability to order up 2 free HIV/STI self-test kits, Combine app + motivational interview, Combine app + motivational interview + ability to order HIV/STI test kits via the app, Combine app with all features except the ability to order self-test kits |
| Motivational interviewThe interview will be grounded in the Social Cognitive Theory of self-regulation (SCT) to reflect the underlying theory of the Combine app. It will be designed to enhance the effectiveness of the app by highlighting app features (e.g., frequently asked questions, product ordering, testing locators) and discussing strategies for following through on goals related to sexual health (e.g., creating and adhering to a testing plan) | Behavioural | Combine app + motivational interview, Combine app + motivational interview + ability to order HIV/STI test kits via the app |
| HIV/STI testingParticipants will be able to order free HIV/STI self-test kits; they will be able to order up to two sets of kits during each of years 1 and 2 of follow-up. HIV and STI test kit orders are independent: ordering an HIV test kit does not trigger shipment of an STI kit and vice versa. When an order is placed, kits containing biospecimen self-collection tools are shipped directly to the participant along with written instructions and a link to video instructions on how to collect each of the samples (e.g., urine, rectal, blood). Return packaging is enclosed with instructions for participants to locate a drop-off location to return their samples to the lab. | Behavioural | Combine app + ability to order up 2 free HIV/STI self-test kits, Combine app + motivational interview + ability to order HIV/STI test kits via the app |
Primary outcome
Uptake of HIV testing
Time frame: Screening, Month 6, Month 12, Month 18, Month 24
The investigator will look at the change in number of participants getting tested for HIV by using online surveys. Uptake of testing will be defined as ordering, using, and returning a kit for laboratory analysis or obtaining a test at an in-person provider and reporting the result.
Uptake of STI testing
Time frame: Screening, Month 6, Month 12, Month 18, Month 24
The investigator will look at the change in number of participants getting tested for STIs by using online surveys. Uptake of testing will be defined as ordering, using, and returning a kit for laboratory analysis or obtaining a test at an in-person provider and reporting the result.
PrEP initiation
Time frame: Screening, Month 6, Month 12, Month 18, Month 24
The investigator will look at the change in number of participants taking PrEP over the course of the study. PrEP initiation will be defined as obtaining a new PrEP prescription for the first time or after a period of non-use of at least three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 40699887Jones J, Manley G, Glynn TR, Wall KM, Baral SD, Harris ED, Benkeser D, Sullivan PS. Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis Initiation Among Rural Men Who Have Sex With Men in the Southern United States: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 23;14:e69540. doi: 10.2196/69540.
- Individual participant dataSharing planned: Yes. Demographics and Primary Outcomes data will be shared upon request.
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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.
Jeb Jones, PhD principal investigator
Rollins School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combine mobile app, Motivational interview and HIV/STI testing in people with HIV Infections and STI, run by Emory University 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 10 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Uptake of HIV testing (time frame: Screening, Month 6, Month 12, Month 18, Month 24). 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?
On the ClinicalTrials.gov record for NCT06205368, which also lists 1 linked publication.
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 30 Oct 2026.