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

NCT03076359 | Completed Results

• 2 other identifiers: 150217K01MH107255-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Retention in Care

  We accessed the percentage of days where participants have medication. For example, if a participant picked up a 30 day supply of medication on August 1st but did not collect their next medication until October 1st, the patient would only be considered retained for 50% of the time.

  Retention in care over 12 months

Secondary Outcomes (1)

• Viral Load

  12 months post-enrollment

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Traditional Healer Support Program

EXPERIMENTAL

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; Drug: Standard of Care

Interventions

Traditional Healer Support Program BEHAVIORAL

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

Also known as: Adherence Support Workers

Traditional Healer Support Program

Standard of Care 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.

Also known as: First Line ART

Standard of Care; Traditional Healer Support Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Namacurra Sede Health Facility

Namacurra, Zambezia Province, Mozambique

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

A pre-post intervention has inherent temporal biases. At the start of the intervention phase Mozambique shifted to a test-and-treat system; the patients in the post-intervention phase are likely substantively different from the pre-group.

Results Point of Contact

• Title: Carolyn Audet
• Organization: Vanderbilt University

carolyn.m.audet@vanderbilt.edu

615-343-2418

Study Officials

• Carolyn Audet, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 10, 2017
• Study Start: June 10, 2015
• Primary Completion: May 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 29, 2020
• Results First Posted: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)