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Interventions to Improve HIV Antiretroviral Therapy Adherence

Primary Purpose

Human Immunodeficiency Virus (HIV) Infection

Status
Completed
Phase
Not Applicable
Locations
Mozambique
Study Type
Interventional
Intervention
Financial Incentive
Reminders
Financial Incentive and Reminders
Information
Stigma-relieving
Information and Stigma-relieving
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Human Immunodeficiency Virus (HIV) Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Munhava Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

No Intervention

Experimental

Experimental

Experimental

Arm Label

Financial Incentive Group

Reminders Group

Financial Incentive and Reminders Group

Control Group

Information Group

Stigma-relieving Group

Information and Stigma-relieving Group

Arm Description

Outcomes

Primary Outcome Measures

Medication possession ratio (MPR) at least 95%, 6 month window
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.

Secondary Outcome Measures

Medication possession ratio (MPR) at least 95%, 3 month window
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.
Medication possession ratio (MPR) at least 80%, 6 month window
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.
Medication possession ratio (MPR) at least 80%, 3 month window
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.
Appointment attendance rate (AAR)
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.
Lost to follow-up (LTFU)
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.
Test Referral, 1-month window
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.

Full Information

First Posted
August 1, 2018
Last Updated
September 22, 2021
Sponsor
University of Michigan
Collaborators
Beira Operational Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03618511
Brief Title
Interventions to Improve HIV Antiretroviral Therapy Adherence
Official Title
Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Beira Operational Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV) Infection

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
914 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Financial Incentive Group
Arm Type
Experimental
Arm Title
Reminders Group
Arm Type
Experimental
Arm Title
Financial Incentive and Reminders Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Arm Title
Information Group
Arm Type
Experimental
Arm Title
Stigma-relieving Group
Arm Type
Experimental
Arm Title
Information and Stigma-relieving Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Financial Incentive
Intervention Description
Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months
Intervention Type
Behavioral
Intervention Name(s)
Reminders
Intervention Description
Reminders: Participants will receive monthly reminder phone calls before their ART medication refill is due for six months.
Intervention Type
Behavioral
Intervention Name(s)
Financial Incentive and Reminders
Intervention Description
Interaction: Participants receive both the Financial Incentives and Reminder Calls.
Intervention Type
Behavioral
Intervention Name(s)
Information
Intervention Description
Information: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART.
Intervention Type
Behavioral
Intervention Name(s)
Stigma-relieving
Intervention Description
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
Intervention Name(s)
Information and Stigma-relieving
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication possession ratio (MPR) at least 95%, 6 month window
Description
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.
Time Frame
0-6 month interval from date of study enrollment
Secondary Outcome Measure Information:
Title
Medication possession ratio (MPR) at least 95%, 3 month window
Description
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.
Time Frame
0-3 month interval from date of study enrollment
Title
Medication possession ratio (MPR) at least 80%, 6 month window
Description
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.
Time Frame
0-6 month interval from date of study enrollment
Title
Medication possession ratio (MPR) at least 80%, 3 month window
Description
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.
Time Frame
0-3 month interval from date of study enrollment
Title
Appointment attendance rate (AAR)
Description
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.
Time Frame
0-6 month interval from date of study enrollment
Title
Lost to follow-up (LTFU)
Description
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.
Time Frame
0-6 month interval from date of study enrollment
Title
Test Referral, 1-month window
Description
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.
Time Frame
1 month interval from date of study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Riddell IV, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Munhava Health Center
City
Beira
State/Province
Sofala
ZIP/Postal Code
2100
Country
Mozambique

12. IPD Sharing Statement

Plan to Share IPD
No

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Interventions to Improve HIV Antiretroviral Therapy Adherence

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