Interventions to Improve HIV Antiretroviral Therapy Adherence in Beira, Mozambique
Last registered on March 03, 2020

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
Last updated
March 03, 2020 7:46 AM EST
Location(s)

This section is unavailable to the public. Use the button below to request access to this information.

Request Information
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
2021-08-16
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. 2020. "Interventions to Improve HIV Antiretroviral Therapy Adherence in Beira, Mozambique." AEA RCT Registry. March 03. https://doi.org/10.1257/rct.3184-4.1.
Former Citation
Mahumane, Arlete et al. 2020. "Interventions to Improve HIV Antiretroviral Therapy Adherence in Beira, Mozambique." AEA RCT Registry. March 03. http://www.socialscienceregistry.org/trials/3184/history/63757.
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
Not available
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

There are documents in this trial unavailable to the public. Use the button below to request access to this information.

Request Information