Interventions to Improve HIV Antiretroviral Therapy Adherence

Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique

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 Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus (HIV) Infection
• Intervention / Treatment: Behavioral: Financial Incentive; Behavioral: Reminders; Behavioral: Financial Incentive and Reminders; Behavioral: Information; Behavioral: Stigma-relieving; Behavioral: Information and Stigma-relieving

• Study Type: Interventional
• Enrollment (Actual): 914
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mozambique
  • Sofala
    • Beira, Sofala, Mozambique, 2100
      • Munhava Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Financial Incentive Group	Behavioral: Financial Incentive; Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months
Experimental: Reminders Group	Behavioral: Reminders; Reminders: Participants will receive monthly reminder phone calls before their ART medication refill is due for six months.
Experimental: Financial Incentive and Reminders Group	Behavioral: Financial Incentive and Reminders; Interaction: Participants receive both the Financial Incentives and Reminder Calls.
Experimental: Information Group	Behavioral: Information; Information: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART.
Experimental: Stigma-relieving Group	Behavioral: Stigma-relieving; Stigma-Reliving: Upon recruitment, inform the participants of the results of a recent population survey regarding people's attitudes towards HIV, if they overestimate the social stigma related to HIV. This intervention intends to reduce the stigma-concern faced by the patients.
Experimental: Information and Stigma-relieving Group	Behavioral: Information and Stigma-relieving; Information and Stigma-relieving: Upon recruitment, show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART. In addition, inform the participants of the results of a recent population survey regarding people's attitudes towards HIV, if they overestimate the social stigma related to HIV. This intervention intends to reduce the stigma-concern faced by the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication possession ratio (MPR) at least 95%, 6 month window	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.	0-6 month interval from date of study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication possession ratio (MPR) at least 95%, 3 month window	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.	0-3 month interval from date of study enrollment
Medication possession ratio (MPR) at least 80%, 6 month window	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.	0-6 month interval from date of study enrollment
Medication possession ratio (MPR) at least 80%, 3 month window	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.	0-3 month interval from date of study enrollment
Appointment attendance rate (AAR)	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.	0-6 month interval from date of study enrollment
Lost to follow-up (LTFU)	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.	0-6 month interval from date of study enrollment
Test Referral, 1-month window	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.	1 month interval from date of study enrollment

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Beira Operational Research Center
• Investigators: Principal Investigator: James Riddell IV, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: HUM00133179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No