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Completed

NCT Number: NCT03618511

Interventions to Improve HIV Antiretroviral Therapy Adherence

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.

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Munhava Health Center

Beira, Sofala, 2100, Mozambique

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Financial incentive

Behavioral

Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months

Reminders

Behavioral

Reminders: Participants will receive monthly reminder phone calls before their ART medication refill is due for six months.

Financial Incentive and Reminders

Behavioral

Interaction: Participants receive both the Financial Incentives and Reminder Calls.

Information

Behavioral

Information: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART.

Stigma-relieving

Behavioral

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

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Beira Operational Research Center

Registry information

Official study title

Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2018
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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