Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT06900634
Eligibility Criteria:
Inclusion Criteria:
FOR MEN
1. living with HIV;
2. AUDIT-C positive (≥4) indicating potential hazardous drinking;
3. \>6 months since initial antiretroviral treatment (ART) initiation;
4. an indicator of potential suboptimal treatment as prevention (TasP) either: (i) last HIV viral load test (within 6 months) was detectable (\>20) or (ii) last viral load test between 6 and 13 months ago was detectable (\>20) and reports missing ≥2 ART doses in the past 2 weeks or (iii) a lack of viral load test results for the prior 13 months in clinic records and reports missing ≥2 ART doses in the past 2 weeks
5. not planning to move from the area within the next 6 months;
6. have their own mobile phone and can be reached via phone.
FOR WOMEN
1. 18+ years of age (or emancipated minor)
2. Pregnant
3. HIV negative
FOR COUPLES (IF INDIVIDUAL ELIGIBILITY CRITERIA ABOVE ARE MET)
1. married/living together \>6 months;
2. planning to stay together \>6 months
3. lived in the area for \>3 months and
4. not planning to move within \<6 months.
5. similar responses on Couple Verification Screening (CVS) form, an instrument to determine if couples are legitimate (e.g., asking each person what they ate the last time they shared a meal with their partner).
Exclusion Criteria:
FOR MEN
1. visibly intoxicated at enrollment (eligible to enroll when not intoxicated);
2. does not speak Luganda or English;
3. currently receiving a majority of work payments via mobile money/digital payments;
4. participated in the Kisoboka pilot RCT;
5. unable to read basic Luganda or English
FOR WOMEN For safety purposes, we will not enroll women who do not feel they can safely participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06900634
Study Brief:
Protocol Section:
NCT06900634