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Clinical Trials/NCT03618511
NCT03618511
Completed
Not Applicable

Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique

University of Michigan1 site in 1 country914 target enrollmentAugust 6, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Immunodeficiency Virus (HIV) Infection
Sponsor
University of Michigan
Enrollment
914
Locations
1
Primary Endpoint
Medication possession ratio (MPR) at least 95%, 6 month window
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 6, 2018
End Date
April 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

James Riddell

Clinical Professor

University of Michigan

Eligibility Criteria

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.

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)
  • Appointment attendance rate (AAR)(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)
  • 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)

Study Sites (1)

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