Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Interventions to Improve HIV Antiretroviral Therapy Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03618511
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Beira Operational Research Center
Information provided by (Responsible Party):
James Riddell, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Infection Behavioral: Financial Incentive Behavioral: Reminders Behavioral: Financial Incentive and Reminders Behavioral: Information Behavioral: Stigma-relieving Behavioral: Information and Stigma-relieving Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Financial Incentive Group Behavioral: Financial Incentive
Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months

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

Experimental: Financial Incentive and Reminders Group Behavioral: Financial Incentive and Reminders
Interaction: Participants receive both the Financial Incentives and Reminder Calls.

No Intervention: Control Group
Experimental: Information Group Behavioral: Information
Information: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART.

Experimental: Stigma-relieving Group Behavioral: 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.

Experimental: Information and Stigma-relieving Group Behavioral: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618511


Contacts
Layout table for location contacts
Contact: James Riddell IV, MD +1-888-229-7409 jriddell@umich.edu

Locations
Layout table for location information
Mozambique
Munhava Health Center Recruiting
Beira, Sofala, Mozambique, 2100
Contact: Arlete ET Mahumane, MD    258 82 642 5947    cynthiwea@gmail.com   
Sponsors and Collaborators
University of Michigan
Beira Operational Research Center
Investigators
Layout table for investigator information
Principal Investigator: James Riddell IV, MD University of Michigan
  Study Documents (Full-Text)

Documents provided by James Riddell, University of Michigan:
Statistical Analysis Plan  [PDF] September 10, 2018


Layout table for additonal information
Responsible Party: James Riddell, Clinical Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03618511     History of Changes
Other Study ID Numbers: HUM00133179
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Immune System Diseases
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents