Interventions to Improve HIV Antiretroviral Therapy Adherence

NCT ID: NCT03618511

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

914 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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Human Immunodeficiency Virus (HIV) Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Financial Incentive Group

Group Type EXPERIMENTAL

Financial Incentive

Intervention Type BEHAVIORAL

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

Reminders Group

Group Type EXPERIMENTAL

Reminders

Intervention Type BEHAVIORAL

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

Financial Incentive and Reminders Group

Group Type EXPERIMENTAL

Financial Incentive and Reminders

Intervention Type BEHAVIORAL

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

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Information Group

Group Type EXPERIMENTAL

Information

Intervention Type BEHAVIORAL

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

Stigma-relieving Group

Group Type EXPERIMENTAL

Stigma-relieving

Intervention Type 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.

Information and Stigma-relieving Group

Group Type EXPERIMENTAL

Information and Stigma-relieving

Intervention Type 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.

Interventions

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Financial Incentive

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

Intervention Type BEHAVIORAL

Reminders

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

Intervention Type BEHAVIORAL

Financial Incentive and Reminders

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

Intervention Type BEHAVIORAL

Information

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

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beira Operational Research Center

UNKNOWN

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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James Riddell

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Riddell IV, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Munhava Health Center

Beira, Sofala, Mozambique

Site Status

Countries

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Mozambique

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HUM00133179

Identifier Type: -

Identifier Source: org_study_id

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