HIV/AIDSNCT04951544
LetSync: Pilot Test of Mobile Health (mHealth) Intervention
A study testing LetSync app in people with HIV/AIDS, run by University of California, San Francisco at 1 site in United States.
Trial summary
The Pilot Test (AKA Study B) will entail a pilot randomized, controlled trial (RCT) of an mHealth behavioral intervention, LetSync, with 80 couples (N=160) to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretroviral concentrations in hair. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- LetSync app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals are eligible if they:
- Self-identify as racial/ethnic minority
- Self-identify as a cisgender man
- Are HIV-Positive themselves, or are the partner of someone who is living with HIV
- Are age 18 or older
- Have a primary relationship partner, defined as someone to whom the participant is committed above anyone else for three or more months
Show all 14Show fewer
- Uses and owns a personal smartphone
- Willing and able to provide informed consent
- Partners are eligible if they:
- Self-identify as a cisgender man
- Are age 18 or older
- Have a primary relationship partner that is the referring participant
- Uses and owns a personal smartphone
- Willing and able to provide informed consent
Who cannot join
- Those who:
- Report fear of intimate partner violence (IPV) resulting from participation
- Are unwilling or unable to disclose HIV status to primary partner
- Present evidence of severe cognitive impairment that would prevent comprehension of study procedures assessed during informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94158
About this study
Official title: Pilot-test of an mHealth Black Men Who Have Sex With Men (MSM) in Couples Intervention (LetSync v1.0, v2.0)
The Pilot Test (AKA Study B) will entail a pilot randomized, controlled trial (RCT) of an mHealth behavioral intervention, LetSync, with 80 couples (N=160) to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretroviral concentrations in hair. Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. In the ensuing 2 months, the investigators will make refinements based on participants' data to produce LetSync v2.0. Then, participants in the waitlist-control arm will receive LetSync v2.0, use it for 6 months, and provide acceptability and feasibility data. The intervention arm will continue using LetSync v1.0, for a total of 14 months. Based on acceptability and feasibility data from waitlist control arm participants between T3 and T4, the investigators will develop LetSync v3.0, which will be used for efficacy testing in a full RCT trial in the future.
- Conditions
- HIV/AIDS
- Being tested
- LetSync app
- Keywords
- HIV/AIDS, mHealth, Intervention, African American men
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetSync appOther
Study B will entail a pilot randomized, controlled trial (RCT) of an app intervention, LetSync, to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretrovirals. Intervention participants will use LetSync and provide data. Participants in the control group do not receive the app and provide data.
The enrollment and analysis approaches differ: To be eligible, Index participants needed to enroll with their partner (i.e., Partner participants). However, for data analyses of the outcomes, we do not separate by Index vs. Partner individuals because we do not analyze individuals by "Index" vs. "Partner", i.e., we include all individuals in analyses who provide the outcomes data of interest. Therefore, we report outcomes by individuals, but in Pre-Assignment Details and Data Tables, we also report number of intact dyads that started and completed the study by Milestone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This arm will start the intervention using LetSync app v1.0 from T1 to T4, baseline/Month 0 to Month 8. Receives: Other: LetSync app |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Urine Samples Returned by Participants
The investigators will use self-collected urine samples as another objective measure of drug adherence for participants living with HIV. The investigators will mail participants a urine sample collection kit with necessary supplies and detailed instructions via online demonstration video. Participants will self-collect and administer the urine sample and send a photo of the results to study staff. Urine test results were collected between baseline (T0) and 8 months (T4) as proportion of samples returned.
Measured: 8 months
Levels of Antiretroviral (ARV, TFVDP) Concentration in Dried Blood Spot (DBS) Samples
The investigators will use the UNC Pharmacology Lab to analyze ARV levels in dried blood spot (DBS) samples as an objective measure of drug adherence and exposure for HIV-infected participants. The investigators will mail participants a DBS sample collection kit with necessary supplies, detailed instructions via online demonstration video, and a prepaid return envelope. DBS samples will be collected and analyzed between baseline (T0) and 8 months (T4).
ARV levels of TFVDP will be measured as nanograms per milligram (ng/mg) of DBS will be log-transformed for data analysis. Changes since Baseline of ARV levels will be measured.
Measured: 8 months
Self-reported Measure of Care Engagement
Self-reported care engagement will be measured with the 10-item Index of Engagement in HIV Care rated on a Likert-type scale ranging from 1 to 5, 'Strongly disagree' to 'Strongly agree'. The minimum summed score is 10, the maximum summed score is 50.
A score will be calculated is the sum of all items without missing responses, with a higher score representing better care engagement and lower score representing worse care engagement.
Measured: 8 months
Secondary outcomes (1)
Number of Participants Retained
Between baseline (T0) and 8 months (T4), the investigators will collect feasibility-related data in terms of number of participants retained in the study from baseline to 8-month (T4) by condition. This is a feasibility and acceptability pilot trial, and one of the main outcomes is acceptability of the trial protocol and procedures, as indicated by participant retention rate, calculated as: The number of participants that remained in the trial divided by the total number of participants at the start of the trial.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start27 Mar 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Judy Y Tan, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951544
- Sponsor's protocol ID
- 5R01MH118967-03
- Other IDs
- 5R01MH118967-03
- Status last verified
- Mar 2026
- First submitted
- 16 Jun 2021
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim HC, Pollack LM, Saberi P, Neilands TB, Arnold EA, Bright DJ, Williams RW, Kegeles SM, Tan JY. Study protocol: a pilot randomised waitlist-controlled trial of a dyadic mobile health intervention for black sexual-minority male couples with HIV in the USA. BMJ Open. 2021 Sep 2;11(9):e055448. doi: 10.1136/bmjopen-2021-055448.
PubMed 34475191
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-test of an mHealth Black Men Who Have Sex With Men (MSM) in Couples Intervention (LetSync v1.0, v2.0)
- ClinicalTrials.gov ID
- NCT04951544
- Acronym / sponsor ID
- 5R01MH118967-03
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, mHealth, Intervention, African American men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Pilot Test (AKA Study B) will entail a pilot randomized, controlled trial (RCT) of an mHealth behavioral intervention, LetSync, with 80 couples (N=160) to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretroviral concentrations in hair. Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. In the ensuing 2 months, the investigators will make refinements based on participants' data to produce LetSync v2.0. Then, participants in the waitlist-control arm will receive LetSync v2.0, use it for 6 months, and provide acceptability and feasibility data. The intervention arm will continue using LetSync v1.0, for a total of 14 months. Based on acceptability and feasibility data from waitlist control arm participants between T3 and T4, the investigators will develop LetSync v3.0, which will be used for efficacy testing in a full RCT trial in the future.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: LetSync appThis arm will start the intervention using LetSync app v1.0 from T1 to T4, baseline/Month 0 to Month 8. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Self-identify as racial/ethnic minority
- Self-identify as a cisgender man
- Are HIV-Positive themselves, or are the partner of someone who is living with HIV
- Are age 18 or older
- Have a primary relationship partner, defined as someone to whom the participant is committed above anyone else for three or more months
Key exclusion criteria (4 listed)
- Report fear of intimate partner violence (IPV) resulting from participation
- Are unwilling or unable to disclose HIV status to primary partner
- Present evidence of severe cognitive impairment that would prevent comprehension of study procedures assessed during informed 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 |
|---|---|---|
| LetSync appStudy B will entail a pilot randomized, controlled trial (RCT) of an app intervention, LetSync, to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretrovirals. Intervention participants will use LetSync and provide data. Participants in the control group do not receive the app and provide data. The enrollment and analysis approaches differ: To be eligible, Index participants needed to enroll with their partner (i.e., Partner participants). However, for data analyses of the outcomes, we do not separate by Index vs. Partner individuals because we do not analyze individuals by "Index" vs. "Partner", i.e., we include all individuals in analyses who provide the outcomes data of interest. Therefore, we report outcomes by individuals, but in Pre-Assignment Details and Data Tables, we also report number of intact dyads that started and completed the study by Milestone. | Other | Intervention Group |
Primary outcome
Proportion of Urine Samples Returned by Participants
Time frame: 8 months
The investigators will use self-collected urine samples as another objective measure of drug adherence for participants living with HIV. The investigators will mail participants a urine sample collection kit with necessary supplies and detailed instructions via online demonstration video. Participants will self-collect and administer the urine sample and send a photo of the results to study staff. Urine test results were collected between baseline (T0) and 8 months (T4) as proportion of samples returned.
Levels of Antiretroviral (ARV, TFVDP) Concentration in Dried Blood Spot (DBS) Samples
Time frame: 8 months
The investigators will use the UNC Pharmacology Lab to analyze ARV levels in dried blood spot (DBS) samples as an objective measure of drug adherence and exposure for HIV-infected participants. The investigators will mail participants a DBS sample collection kit with necessary supplies, detailed instructions via online demonstration video, and a prepaid return envelope. DBS samples will be collected and analyzed between baseline (T0) and 8 months (T4). ARV levels of TFVDP will be measured as nanograms per milligram (ng/mg) of DBS will be log-transformed for data analysis. Changes since Baseline of ARV levels will be measured.
Self-reported Measure of Care Engagement
Time frame: 8 months
Self-reported care engagement will be measured with the 10-item Index of Engagement in HIV Care rated on a Likert-type scale ranging from 1 to 5, 'Strongly disagree' to 'Strongly agree'. The minimum summed score is 10, the maximum summed score is 50. A score will be calculated is the sum of all items without missing responses, with a higher score representing better care engagement and lower score representing worse care engagement.
1 secondary outcome
Number of Participants Retained
Time frame: 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34475191Kim HC, Pollack LM, Saberi P, Neilands TB, Arnold EA, Bright DJ, Williams RW, Kegeles SM, Tan JY. Study protocol: a pilot randomised waitlist-controlled trial of a dyadic mobile health intervention for black sexual-minority male couples with HIV in the USA. BMJ Open. 2021 Sep 2;11(9):e055448. doi: 10.1136/bmjopen-2021-055448.
- Individual participant dataSharing planned: No
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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.
Judy Y Tan, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LetSync app in people with HIV/AIDS, run by University of California, San Francisco 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 14 inclusion and 4 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 23 Mar 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?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Urine Samples Returned by Participants (time frame: 8 months). 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 NCT04951544, 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 23 Mar 2026.