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Traditional Healers as Adherence Partners for Persons Living With HIV in Rural Mozambique (PLHIV)

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ClinicalTrials.gov Identifier: NCT03076359
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Carolyn Audet, Vanderbilt University Medical Center

Brief Summary:
The overall goal of this project is to adapt and assess the impact of a traditional healer training program/intervention on the adherence, retention, and viral load of HIV infected patients newly initiated on anti-retroviral therapy (ART) in rural Mozambique.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Traditional Healer Support Program Drug: Standard of Care Not Applicable

Detailed Description:

Incorporating healers as anti-retroviral therapy (ART) adherence counselors can help reduce the crisis of HIV treatment abandonment. Healers are often accused of encouraging patients to abandon HIV care, but they can also serve as strong advocates for patient health. When healers were engaged as tuberculosis (TB) adherence counselors in South Africa, their patients were as successful as those supported by non-healer counselors. An innovative solution would be to engage trained healers as treatment partners to support medication and appointment adherence for PLHIV.

Healers are well positioned to address reported patient concerns, including: (1) keeping a patients HIV status a secret while providing support; (2) assisting with partner disclosure and initiating community/clinical systems of assistance if gender base violence is threatened/occurs; and (3) advocating for patients during clinical visits to ensure quality care is provided. Other programs in SSA have shown that incorporating healers into an allopathic health system as adherence supporters for TB treatment is feasible, but healer use in HIV treatment is not well-documented. This novel intervention would provide patients newly initiated on ART a choice to nominate a specially trained healer as a treatment partner, and assess acceptability, feasibility, and patient outcomes using an interrupted time series quasi-experimental design. Community-based treatment partners can improve pharmacy adherence and loss to follow up (LTFU), while decreasing stigma and isolation.

Engaging healers to conduct counseling sessions in a community setting to improve ART adherence necessitates technical clinical and psychosocial training. The ART Adherence Support Worker Training program (from FHI 360) will be adapted (using ADAPT-ITT) and used to train healers to be quality treatment partners and advocates. The training will ensure healers have the knowledge and skills to effectively: (1) Educate PLHIV about ART and HIV care; (2) Assess serious ART side effects or HIV co-infections; (3) Counsel patients about safer strategies for partner disclosure (with assistance if needed); (4) Accompany the patient for each clinical appointment; and (5) Advocate for quality health care delivery when assisting each patient. The FGH training team will conduct training of the healers. All patients initiating ART will be screened for interest in having a healer treatment partner. Control and intervention patients will be followed for one year, allowing the investigators to compare outcomes at 12-months to study the effectiveness of healers as adherence partners.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Traditional Healers as Adherence Partners for PLHIV in Rural Mozambique
Actual Study Start Date : June 10, 2015
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Standard of Care
Intervention: This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
Drug: Standard of Care
First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
Other Name: First Line ART

Experimental: Traditional Healer Support Program

This group will receive standard of care as described above. In addition, the investigators will assess an intervention partnership with traditional healer including: community and clinic based support from a trained traditional healer.

The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services. In addition, the healer will accompany the patient on all regularly scheduled clinical visits.

Behavioral: Traditional Healer Support Program
Traditional Healers will provide the "traditional healer support program" assistance, as previously described, to all newly diagnosed patients.
Other Name: Adherence Support Workers

Drug: Standard of Care
First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
Other Name: First Line ART




Primary Outcome Measures :
  1. Retention in Care [ Time Frame: 3, 6, and 12 months post-enrollment ]
    Patient retention to clinical visits and medication pick up as directed by clinicians


Secondary Outcome Measures :
  1. Viral Load [ Time Frame: 12 months post-enrollment ]
    Patient viral load at 12 months to assess the impact of the intervention on HIV viral suppression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients: Individuals 18 years of age or older, HIV-infected, and newly enrolled in ART and treatment services at Namacurra Sede.
  • Traditional Healers: Healers will be eligible to participate if the healer lives within 10 km of the Namacurra Sede, received previous training from FGH, is 18 years of age or older, speak Portuguese, and see at least one patient per month

Exclusion Criteria:

  • Patients: Individuals that are currently pregnant, HIV-uninfected, and/or not yet enrolled in HIV care. Individuals who cannot give consent due to mental limitations or intoxication.
  • Traditional Healers: Healers who believe they can effectively treat or cure HIV or other associated conditions will be excluded from the project.

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): NCT03076359


Locations
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Mozambique
Namacurra Sede Health Facility
Namacurra, Zambezia, Mozambique
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Carolyn Audet, PhD Vanderbilt University

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Responsible Party: Carolyn Audet, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03076359     History of Changes
Other Study ID Numbers: 150217
K01MH107255-01 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents