Human Immunodeficiency VirusPATHNCT05427318
Peers Plus Mobile App for Treatment in HIV
A study testing PATH in people with Human Immunodeficiency Virus, run by San Diego State University at 1 site in United States.
Trial summary
This study called "Peers plus mobile App for Treatment in HIV (PATH)" is a two-arm randomized controlled trial (RCT) evaluating the efficacy of an intervention that combines peer navigation and mobile health (mHealth) technology to support HIV care outcomes among Hispanic and Black Persons Living with HIV (HBPLH). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- PATH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 25 Jul 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Can read and speak English or Spanish
- Self-reported diagnosis of HIV by a physician or healthcare provider
- Currently prescribed HIV medication
- Having access to an internet browser on a home computer, tablet, or smart phone
- Does not plan to move out of the San Diego area in the next 12 months
Show all 12Show fewer
- Meets one or more of the following medical chart verified or self-reported criteria
- One or more detectable viral load test result (>200 copies m/L) in the past 12-months while on antiretroviral therapy for at least 3 months
- Having missed 1 or more scheduled HIV care appointments in the last 12 months
- Last HIV care visit was more than 6 months ago
- Self-reporting less than 90% antiretroviral therapy adherence in the last 4 weeks using the Wilson-3 scale
- Report stimulant or opioid use (non-prescription) in the past 6 months
Who cannot join
- <18 years old
- Currently enrolled in any program, intervention, or research study designed to improve antiretroviral therapy adherence or engagement in HIV care (e.g., LinkPositively)
- Members of one of the community advisory boards providing advisement on the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peers Plus Mobile App for Treatment in HIV (PATH)
This study called "Peers plus mobile App for Treatment in HIV (PATH)" is a two-arm randomized controlled trial (RCT) evaluating the efficacy of an intervention that combines peer navigation and mobile health (mHealth) technology to support HIV care outcomes among Hispanic and Black Persons Living with HIV (HBPLH).
Read the detailed description
PATH is a community-academic collaboration with a federally qualified health center serving patients in South San Diego under the Ryan White model of care.
The scientific premise of this RCT is that combining two interventions developed by this team (peer navigation + mHealth) into a single mHealth peer navigation intervention (PATH) will eliminate the need for in-person support from peer navigators, promote high impact on HIV care continuum outcomes, as well as extend broader reach to underserved communities.
The RCT will test the efficacy of PATH with 375 HBPLH (among whom >33% will report stimulant and/or opioid use in the past 6 months).
Aim 1. Improve the primary outcomes - sustained viral suppression (i.e., suppressed viral load at both 6- and 12-month follow-up), and secondary outcomes (e.g., retention in care) compared to usual care.
Sub-aim 1: Explore subgroup differences in efficacy based on factors like race/ethnicity and substance use.
Aim 2. Examine the theory-informed mediators (e.g., self-efficacy to engage in HIV care, HIV stigma) through which PATH has the greatest impact on sustained viral suppression among HBPLH.
Aim 3. Explore whether PATH significantly affects substance-related outcomes (e.g., frequency of substance use, engagement in substance abuse treatment) when compared to usual care among those using substances (i.e., stimulants and/or opioids).
- Conditions
- Human Immunodeficiency Virus
- Being tested
- PATH
- Keywords
- HIV, Telemedicine, Substance use
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATHBehavioural
Also called Camino
The intervention integrates two theoretically-grounded interventions - one with a strong peer navigator component and the other with a scalable mHealth component - into the intervention called Peers plus mobile App for Treatment in HIV (PATH)
| Study group | Role | What they receive |
|---|---|---|
| PATH Active Intervention Arm | Active comparator | Participants assigned to this group will receive care as usual if they are assigned to this group. In addition, participants in this arm will receive HIV care support from a trained peer navigator and have access to a mHealth web application designed to support their health and HIV care. Receives: Behavioral: PATH |
| Usual Care | No intervention | Participants assigned to this group are in the control arm and will receive standard of care following the Ryan White model of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression
Having an undetectable HIV viral load; <200 copies/mL
Measured: 6 months
Viral suppression
Having an undetectable HIV viral load; <200 copies/mL
Measured: 12 months
Secondary outcomes (8)
Retention in HIV care
Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart
Measured: 6 months
Retention in HIV care
Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart
Measured: 12 months
Gap in HIV medical visits
Health Resources and Services Administration definition: no HIV medical visits in last 6 months
Measured: 6 months
Gap in HIV medical visits
Health Resources and Services Administration definition: no HIV medical visits in last 6 months
Measured: 12 months
Antiretroviral therapy adherence
Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)
Measured: 3 months
Antiretroviral therapy adherence
Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)
Measured: 6 months
Antiretroviral therapy adherence
Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)
Measured: 9 months
Antiretroviral therapy adherence
Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Nov 2021
- Primary completion14 Jun 2025
- Study completion25 Jul 2025
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 Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by San Diego State 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427318
- Sponsor's protocol ID
- R01DA053167
- Acronym
- PATH
- Status last verified
- Sep 2025
- First submitted
- 15 Jun 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pitpitan EV, Horvath KJ, Aldous J, Stockman JK, Patterson TL, Liang M, Barrozo C, Moore V, Penninga K, Smith LR. Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV. Trials. 2024 Mar 22;25(1):212. doi: 10.1186/s13063-024-08042-8.
PubMed 38520030
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peers Plus Mobile App for Treatment in HIV (PATH)
- ClinicalTrials.gov ID
- NCT05427318
- Acronym / sponsor ID
- PATH / R01DA053167
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, Telemedicine, Substance use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 14 Jun 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 22 Jun 2022 (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.
This study called "Peers plus mobile App for Treatment in HIV (PATH)" is a two-arm randomized controlled trial (RCT) evaluating the efficacy of an intervention that combines peer navigation and mobile health (mHealth) technology to support HIV care outcomes among Hispanic and Black Persons Living with HIV (HBPLH).
Detailed description
PATH is a community-academic collaboration with a federally qualified health center serving patients in South San Diego under the Ryan White model of care.
The scientific premise of this RCT is that combining two interventions developed by this team (peer navigation + mHealth) into a single mHealth peer navigation intervention (PATH) will eliminate the need for in-person support from peer navigators, promote high impact on HIV care continuum outcomes, as well as extend broader reach to underserved communities.
The RCT will test the efficacy of PATH with 375 HBPLH (among whom >33% will report stimulant and/or opioid use in the past 6 months).
Aim 1. Improve the primary outcomes - sustained viral suppression (i.e., suppressed viral load at both 6- and 12-month follow-up), and secondary outcomes (e.g., retention in care) compared to usual care.
Sub-aim 1: Explore subgroup differences in efficacy based on factors like race/ethnicity and substance use.
Aim 2. Examine the theory-informed mediators (e.g., self-efficacy to engage in HIV care, HIV stigma) through which PATH has the greatest impact on sustained viral suppression among HBPLH.
Aim 3. Explore whether PATH significantly affects substance-related outcomes (e.g., frequency of substance use, engagement in substance abuse treatment) when compared to usual care among those using substances (i.e., stimulants and/or opioids).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PATH Active Intervention Arm | Active comparator | Behavioral: PATHParticipants assigned to this group will receive care as usual if they are assigned to this group. In addition, participants in this arm will receive HIV care support from a trained peer navigator and have access to a mHealth web application designed to support their health and HIV care. |
| Usual Care | No intervention | –Participants assigned to this group are in the control arm and will receive standard of care following the Ryan White model of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥18 years old
- Can read and speak English or Spanish
- Self-reported diagnosis of HIV by a physician or healthcare provider
- Currently prescribed HIV medication
- Having access to an internet browser on a home computer, tablet, or smart phone
Key exclusion criteria (3 listed)
- <18 years old
- Currently enrolled in any program, intervention, or research study designed to improve antiretroviral therapy adherence or engagement in HIV care (e.g., LinkPositively)
- Members of one of the community advisory boards providing advisement on the study.
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 |
|---|---|---|
| PATHAlso: CaminoThe intervention integrates two theoretically-grounded interventions - one with a strong peer navigator component and the other with a scalable mHealth component - into the intervention called Peers plus mobile App for Treatment in HIV (PATH) | Behavioural | PATH Active Intervention Arm |
Primary outcome
Viral suppression
Time frame: 6 months
Having an undetectable HIV viral load; <200 copies/mL
Viral suppression
Time frame: 12 months
Having an undetectable HIV viral load; <200 copies/mL
8 secondary outcomes
Retention in HIV care
Time frame: 6 months
Retention in HIV care
Time frame: 12 months
Gap in HIV medical visits
Time frame: 6 months
Gap in HIV medical visits
Time frame: 12 months
Antiretroviral therapy adherence
Time frame: 3 months
Antiretroviral therapy adherence
Time frame: 6 months
Antiretroviral therapy adherence
Time frame: 9 months
Antiretroviral therapy adherence
Time frame: 12 months
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 24 Sep 2025.
- Derived from this study: PubMed 38520030Pitpitan EV, Horvath KJ, Aldous J, Stockman JK, Patterson TL, Liang M, Barrozo C, Moore V, Penninga K, Smith LR. Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV. Trials. 2024 Mar 22;25(1):212. doi: 10.1186/s13063-024-08042-8.
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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 PATH in people with Human Immunodeficiency Virus, run by San Diego State 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 12 inclusion and 3 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 24 Sep 2025. 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?
Viral suppression (time frame: 6 months). The study lists 2 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 NCT05427318, 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 24 Sep 2025.