Interventions to Improve HIV Antiretroviral Therapy Adherence

NCT03618511 | Completed

• 1 other identifier: HUM00133179
• Study Type: interventional
• Target: 914
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus (HIV) Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Appointment attendance rate (AAR)

  0-6 month interval from date of study enrollment

• Lost to follow-up (LTFU)

  0-6 month interval from date of study enrollment

Study Arms (7)

Financial Incentive Group

EXPERIMENTAL

Behavioral: Financial Incentive

Reminders Group

EXPERIMENTAL

Behavioral: Reminders

Financial Incentive and Reminders Group

EXPERIMENTAL

Behavioral: Financial Incentive and Reminders

Control Group

NO INTERVENTION

Information Group

EXPERIMENTAL

Behavioral: Information

Stigma-relieving Group

EXPERIMENTAL

Behavioral: Stigma-relieving

Information and Stigma-relieving Group

EXPERIMENTAL

Behavioral: Information and Stigma-relieving

Interventions

Financial Incentive BEHAVIORAL

Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months

Financial Incentive Group

Reminders BEHAVIORAL

Reminders: Participants will receive monthly reminder phone calls before their ART medication refill is due for six months.

Reminders Group

Financial Incentive and Reminders BEHAVIORAL

Interaction: Participants receive both the Financial Incentives and Reminder Calls.

Financial Incentive and Reminders Group

Information BEHAVIORAL

Information: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART.

Information Group

Stigma-relieving BEHAVIORAL

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.

Stigma-relieving Group

Information and Stigma-relieving BEHAVIORAL

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.

Information and Stigma-relieving Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Beira Operational Research Center: collaborator

Study Sites (1)

Munhava Health Center

Beira, Sofala, 2100, Mozambique

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• James Riddell IV, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 7, 2018
• Study Start: August 6, 2018
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)