- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03618511
Interventions to Improve HIV Antiretroviral Therapy Adherence
September 22, 2021 updated by: James Riddell, University of Michigan
Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
914
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sofala
-
Beira, Sofala, Mozambique, 2100
- Munhava Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
|
|
Experimental: Financial Incentive Group
|
Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months
|
Experimental: Reminders Group
|
Reminders: Participants will receive monthly reminder phone calls before their ART medication refill is due for six months.
|
Experimental: Financial Incentive and Reminders Group
|
Interaction: Participants receive both the Financial Incentives and Reminder Calls.
|
Experimental: Information Group
|
Information: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART.
|
Experimental: Stigma-relieving Group
|
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.
|
Experimental: Information and Stigma-relieving Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication possession ratio (MPR) at least 95%, 6 month window
Time Frame: 0-6 month interval from date of study enrollment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication possession ratio (MPR) at least 95%, 3 month window
Time Frame: 0-3 month interval from date of study enrollment
|
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.
|
0-3 month interval from date of study enrollment
|
Medication possession ratio (MPR) at least 80%, 6 month window
Time Frame: 0-6 month interval from date of study enrollment
|
Fraction of participants for whom MPR is greater than or equal to 80%.
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
|
Medication possession ratio (MPR) at least 80%, 3 month window
Time Frame: 0-3 month interval from date of study enrollment
|
Fraction of participants for whom MPR is greater than or equal to 80%.
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.
|
0-3 month interval from date of study enrollment
|
Appointment attendance rate (AAR)
Time Frame: 0-6 month interval from date of study enrollment
|
Average AAR among participants.
AAR is proportion of scheduled visits completed during the observation period.
"Completed visit" considered done if patient visits clinic on scheduled appointment date, or up to 7 days prior to that date.
AAR is computed from clinic 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
|
Lost to follow-up (LTFU)
Time Frame: 0-6 month interval from date of study enrollment
|
Fraction of participants lost to follow up (LTFU).
LTFU indicates patient missed last appointment and 90 or more days have elapsed since patient's last scheduled appointment date, with no clinic record of contact since that date.
Patients who transfer clinics or opt out of future study participation are excluded from LTFU denominator, but those who die are retained in LTFU denominator.
|
0-6 month interval from date of study enrollment
|
Test Referral, 1-month window
Time Frame: 1 month interval from date of study enrollment
|
This is a binary variable, which takes value 1 if the participant has a successful referral to test for HIV within 1 month of recruitment and 0 otherwise.
A participant is considered having a successful referral if someone approaches our study team in the clinic, present us with the proof of an HIV testing together with the barcode-card we distributed to the participant upon recruitment.
|
1 month interval from date of study enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James Riddell IV, MD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2018
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
August 1, 2018
First Submitted That Met QC Criteria
August 1, 2018
First Posted (Actual)
August 7, 2018
Study Record Updates
Last Update Posted (Actual)
September 24, 2021
Last Update Submitted That Met QC Criteria
September 22, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- HUM00133179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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