Interventions to Improve HIV Antiretroviral Therapy Adherence

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus (HIV) Infection
• Interventions: Behavioral: Information; Behavioral: Reminders; Behavioral: Financial Incentive and Reminders; Behavioral: Financial Incentive; Behavioral: Stigma-relieving; Behavioral: Information and Stigma-relieving

• Registration Number: NCT03618511
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Study Start: 2018-08-06
• Study First Posted: 2018-08-07
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 914

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.

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Exclusion Criteria

• Not infected with HIV;
• On ART for more than 90 days;
• Do not have a private phone.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Information Group	Information	-
Reminders Group	Reminders	-
Financial Incentive and Reminders Group	Financial Incentive and Reminders	-
Financial Incentive Group	Financial Incentive	-
Stigma-relieving Group	Stigma-relieving	-
Information and Stigma-relieving Group	Information and Stigma-relieving	-

Primary Outcome Measures

Name	Time	Method
Medication possession ratio (MPR) at least 95%, 6 month window	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 Outcome Measures

Name	Time	Method
Test Referral, 1-month window	1 month interval from date of study enrollment	This is a binary variable, which takes value 1 if the participant has a successful referral to test for HIV within 1 month of recruitment and 0 otherwise. A participant is considered having a successful referral if someone approaches our study team in the clinic, present us with the proof of an HIV testing together with the barcode-card we distributed to the participant upon recruitment.
Lost to follow-up (LTFU)	0-6 month interval from date of study enrollment	Fraction of participants lost to follow up (LTFU). LTFU indicates patient missed last appointment and 90 or more days have elapsed since patient's last scheduled appointment date, with no clinic record of contact since that date. Patients who transfer clinics or opt out of future study participation are excluded from LTFU denominator, but those who die are retained in LTFU denominator.
Medication possession ratio (MPR) at least 95%, 3 month window	0-3 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.
Appointment attendance rate (AAR)	0-6 month interval from date of study enrollment	Average AAR among participants. AAR is proportion of scheduled visits completed during the observation period. "Completed visit" considered done if patient visits clinic on scheduled appointment date, or up to 7 days prior to that date. AAR is computed from clinic records. Measurement window truncated to last visit date for patients who transfer clinics, opt out of future study participation, or die.
Medication possession ratio (MPR) at least 80%, 6 month window	0-6 month interval from date of study enrollment	Fraction of participants for whom MPR is greater than or equal to 80%. 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.
Medication possession ratio (MPR) at least 80%, 3 month window	0-3 month interval from date of study enrollment	Fraction of participants for whom MPR is greater than or equal to 80%. 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.

Trial Locations

Locations (1)

Munhava Health Center; 🇲🇿 Beira, Sofala, Mozambique