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Interventions to Improve HIV Antiretroviral Therapy Adherence in Beira, Mozambique

Last registered on August 23, 2019

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 23, 2019, 1:51 PM 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
Beira Operational Research Center
PI Affiliation
University of Michigan
PI Affiliation
University of Michigan

Additional Trial Information

Status
On going
Start date
2018-08-06
End date
2020-03-16
Secondary IDs
clinicaltrials.gov: NCT03618511
Abstract
This study will explore whether financial incentives and reminders help improve anti-retroviral therapy (ART) adherence among HIV infected individuals. The interventions will be randomized in the study population in a cross-cutting design, with 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. This design allows estimation of complementarities between the two interventions. The primary outcome of interest will be adherence to ART, as measured by the medication possession ratio (MPR) over 6 months.
External Link(s)

Registration Citation

Citation
Mahumane, Arlete et al. 2019. "Interventions to Improve HIV Antiretroviral Therapy Adherence in Beira, Mozambique." AEA RCT Registry. August 23. https://doi.org/10.1257/rct.3184-4.0
Former Citation
Mahumane, Arlete et al. 2019. "Interventions to Improve HIV Antiretroviral Therapy Adherence in Beira, Mozambique." AEA RCT Registry. August 23. https://www.socialscienceregistry.org/trials/3184/history/52240
Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2018-08-06
Intervention End Date
2019-03-11

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. The interventions will last for 6 months.
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
1200 individuals
Sample size: planned number of observations
1200 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 treatment.
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