Interventions to Improve HIV Antiretroviral Therapy Adherence in Beira, Mozambique

Last registered on August 07, 2021

Pre-Trial

Trial Information

General Information

Title
Interventions to Improve HIV Antiretroviral Therapy Adherence in Beira, Mozambique
RCT ID
AEARCTR-0003184
Initial registration date
September 10, 2018

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 11, 2018, 2:02 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
August 07, 2021, 4:51 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Region

Primary Investigator

Affiliation
University of Michigan

Other Primary Investigator(s)

PI Affiliation
University of Michigan
PI Affiliation
University of Michigan
PI Affiliation
Beira Operational Research Center

Additional Trial Information

Status
On going
Start date
2018-08-06
End date
2021-12-31
Secondary IDs
clinicaltrials.gov: NCT03618511
Abstract
The long-term goal is to understand the barriers that HIV patients in sub-Saharan Africa face in adhering to antiretroviral therapy (ART) and develop interventions to improve adherence that may be scaled up. Many people living with HIV in sub-Saharan Africa fail to adhere to ART, the medical treatment for HIV that can stop the virus from progressing to AIDS and also prevents transmission to others. This study seeks to identify the barriers to treatment adherence and develop interventions to improve adherence. We recruit patients who are newly diagnosed with HIV infection and prescribed ART from a large health center in Mozambique. For patients who meet the study qualifications, we randomly assign them to receive standard of care versus reminder phone calls, a monetary incentive or both. Other interventions aim to increase knowledge regarding HIV infection and decrease stigma. We track the medication possession ratio (MPR) after six months to evaluate the various interventions. To shed light on the spillovers of the interventions, we offer coupons for the participants to refer their partners to get tested. The experiment result will inform us of behavioral patterns of the population that are economically and physically vulnerable. Effective interventions are ready to be scaled up in HIV-treatment facilities in resource-constrained environments.
External Link(s)

Registration Citation

Citation
Mahumane, Arlete et al. 2021. "Interventions to Improve HIV Antiretroviral Therapy Adherence in Beira, Mozambique." AEA RCT Registry. August 07. https://doi.org/10.1257/rct.3184-4.199999999999999
Former Citation
Mahumane, Arlete et al. 2021. "Interventions to Improve HIV Antiretroviral Therapy Adherence in Beira, Mozambique." AEA RCT Registry. August 07. https://www.socialscienceregistry.org/trials/3184/history/97274
Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2018-08-06
Intervention End Date
2021-08-11

Primary Outcomes

Primary Outcomes (end points)
Medication possession ratio (MPR) at least 95%, 6-month window
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Participants will be randomized with equal probability to a control group, a financial incentive treatment group, a reminder phone call treatment group, and a treatment group that receives both reminder calls and financial incentives, an anti-stigma intervention group, an HIV/ART knowledge intervention group, a group that receives both the anti-stigma and the knowledge intervention group. The financial incentive and the phone call reminder interventions will last for 6 months. The informational interventions are one-time conducted at the time of recruitment.
Experimental Design Details
Randomization Method
Randomization done in the office by a computer.
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
2100 individuals
Sample size: planned number of observations
2100 individuals
Sample size (or number of clusters) by treatment arms
300 individuals control, 300 individuals financial incentive, 300 individuals phone call reminders, 300 individuals both the financial incentive and reminder intervention, 300 anti-stigma intervention, 300 HIV/ART knowledge intervention, 300 both anti-stigma and knowledge intervention
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
University of Michigan Medical School Institutional Review Board (IRBMED)
IRB Approval Date
2017-11-30
IRB Approval Number
HUM00133179
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials