Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 914
- Locations
- 1
- Primary Endpoint
- Medication possession ratio (MPR) at least 95%, 6 month window
Study Overview
Brief Summary
This study will explore whether financial incentives, reminders, information about HIV/AIDS and its treatment and anti-stigma counseling help improve anti-retroviral therapy (ART) adherence among HIV infected individuals in a resource-limited environment. The interventions will be randomized in the study population in a cross-cutting design, with a control group, a financial incentive treatment group, a reminders treatment group, a treatment group that receives both the financial incentive and reminder interventions. In addition, there will be an information treatment group, a stigma-relieving treatment group and a group that receives both information and stigma-relieving interventions. The primary outcomes of interest for this study will be the adherence to ART, measured by attendance rates at clinic appointments and refill collection rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infected with HIV;
- •Have not start ART, or started ART less than 90 days before;
- •Have a phone number on which can discuss private health matters.
Exclusion Criteria
- •Not infected with HIV;
- •On ART for more than 90 days;
- •Do not have a private phone.
Arms & Interventions
Information and Stigma-relieving Group
Intervention: Information and Stigma-relieving (Behavioral)
Financial Incentive Group
Intervention: Financial Incentive (Behavioral)
Reminders Group
Intervention: Reminders (Behavioral)
Financial Incentive and Reminders Group
Intervention: Financial Incentive and Reminders (Behavioral)
Control Group
Information Group
Intervention: Information (Behavioral)
Stigma-relieving Group
Intervention: Stigma-relieving (Behavioral)
Outcomes
Primary Outcomes
Medication possession ratio (MPR) at least 95%, 6 month window
Time Frame: 0-6 month interval from date of study enrollment
Fraction of participants for whom MPR is greater than or equal to 95%. MPR is proportion of days that a respondent is in possession of at least one ART dose. MPR is computed from pharmacy dispensing records. Measurement window truncated to last visit date for patients who transfer clinics, opt out of future study participation, or die.
Secondary Outcomes
- Test Referral, 1-month window(1 month interval from date of study enrollment)
- Lost to follow-up (LTFU)(0-6 month interval from date of study enrollment)
- Medication possession ratio (MPR) at least 95%, 3 month window(0-3 month interval from date of study enrollment)
- Appointment attendance rate (AAR)(0-6 month interval from date of study enrollment)
- Medication possession ratio (MPR) at least 80%, 6 month window(0-6 month interval from date of study enrollment)
- Medication possession ratio (MPR) at least 80%, 3 month window(0-3 month interval from date of study enrollment)
Investigators
James Riddell
Clinical Professor
University of Michigan