Interventions to Improve HIV Antiretroviral Therapy Adherence

Human Immunodeficiency Virus (HIV) Infection Clinical Trial

Official title:

Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618511
• Other study ID #: HUM00133179
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 914
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV) Infection

Intervention

Behavioral:
• Financial Incentive
Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months
• Reminders
Reminders: Participants will receive monthly reminder phone calls before their ART medication refill is due for six months.
• Financial Incentive and Reminders
Interaction: Participants receive both the Financial Incentives and Reminder Calls.
• Information
Information: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART.
• Stigma-relieving
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.
• Information and Stigma-relieving
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.

Locations

Country	Name	City	State
Mozambique	Munhava Health Center	Beira	Sofala

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Beira Operational Research Center

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-6 month interval from date of study enrollment
Secondary	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.	0-3 month interval from date of study enrollment
Secondary	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.	0-6 month interval from date of study enrollment
Secondary	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.	0-3 month interval from date of study enrollment
Secondary	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.	0-6 month interval from date of study enrollment
Secondary	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.	0-6 month interval from date of study enrollment
Secondary	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.	1 month interval from date of study enrollment