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

NCT ID: NCT03076359

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-10
• Study Completion Date: 2019-06-30

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 in rural Mozambique.

Detailed Description

Incorporating healers as anti-retroviral therapy 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 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 people living with HIV.

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 sub-Saharan Africa 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 , while decreasing stigma and isolation.

Engaging healers to conduct counseling sessions in a community setting to improve ART adherence necessitates technical clinical and psycho-social training. The ART Adherence Support Worker Training program will be adapted 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 people living with HIV about treatment and HIV care; (2) Assess serious medication 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 training team will conduct training of the healers. All patients initiating treatment 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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Traditional Healer Support Program

Intervention Type: BEHAVIORAL

Traditional Healers will provide the "traditional healer support program" assistance, as previously described, to all newly diagnosed patients.

Standard of Care

Intervention Type: DRUG

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.

Interventions

Traditional Healer Support Program

Traditional Healers will provide the "traditional healer support program" assistance, as previously described, to all newly diagnosed patients.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Other Intervention Names

Adherence Support Workers; First Line ART

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Audet

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Audet, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Namacurra Sede Health Facility

Namacurra, Zambezia Province, Mozambique

Countries

Mozambique

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

K01MH107255-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

150217

Identifier Type: -

Identifier Source: org_study_id