A Novel Approach to Community-based HIV Testing With Traditional Healers in Mwanza, Tanzania

HIV antiretroviral therapy (ART) has the potential to dramatically decrease HIV transmission worldwide. In Tanzania, HIV prevalence is ~5%, with 1.6 million people living with HIV/AIDS; it is the leading cause of hospitalization and death among Tanzanian adults. However, less than 50% of HIV-infected Tanzanian adults know their status.Successful implementation of community-based services requires an understanding of the social and cultural context that influence community engagement with HIV services. Specifically, many HIV endemic regions are also medically pluralistic communities, where multiple explanatory frameworks for health and disease co-exist. In these areas, HIV testing and ART clinical care do not occur in isolation; traditional healers are commonly utilized instead of or concurrently with biomedical services. Therefore, the success of decentralized, community-based HIV services must be founded upon a thorough understanding of medical pluralism, and engagement with traditional healers as stakeholders in community health.

This study will investigate the feasibility of involving traditional healers in HIV testing, and pilot an intervention to expand HIV testing within communities that use traditional medicine in Mwanza, Tanzania.

Study Overview

• Status: Completed
• Conditions: HIV; Health Behavior
• Intervention / Treatment: Diagnostic test: Point-of-care HIV testing; Behavioral: HIV testing education

Detailed Description

This study has two specific aims.

Specific Aim 1:

Tailor a point of care HIV testing intervention for delivery in northwestern Tanzania, using data from 1) qualitative interviews and 2) community engagement strategies. Interviews with traditional healers, traditional and biomedical clients, and HIV clinic staff will illustrate local variables impacting HIV testing engagement. A community advisory board with stakeholder members will guide program implementation, tailoring protocols to maximize uptake.

Specific Aim 2:

Conduct a cluster-randomized pilot of the HIV testing intervention. This pilot will offer HIV testing at five traditional healer practice sites, compared with a control group of five healers providing education on community HIV resources..

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Mwanza, Tanzania
    • National Institute for Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• Not known to be HIV-infected
• Client of a traditional healer practice
• Willing to be contacted for monthly follow-up for three months
• Willing to complete an exit survey at the end of three months
• Able to provide informed consent

Inclusion specific to point-of-care HIV testing intervention:

• Willing to have point of care HIV test
• Willing to receive results of HIV test

Exclusion Criteria:

• less than 18 years of age
• Known to be HIV-infected
• Unable to provide informed consent
• Unwilling to participate in follow-up

Exclusion specific to point-of-care HIV testing intervention:

• Unwilling to have point-of-care HIV test
• Unwilling to receive the results of HIV test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Point-of-care HIV testing (intervention); Participants will be offered voluntary point-of-care HIV testing during a traditional healer visit.	Diagnostic test: Point-of-care HIV testing; Participants will undergo an HIV 1/2 antibody point of care test (Oraquick) and receive pre- and post-test counselling.Participants with positive tests will be referred to the HIV clinic for Western Blot confirmation, and linkage to care.
ACTIVE_COMPARATOR: Education on community HIV resources (control); Participants will be offered education regarding HIV testing and community resources during a traditional healer visit.	Behavioral: HIV testing education; Participants will be provided with education on community based HIV resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of HIV testing	Rate of HIV testing among clients of traditional healers who were offered point-of-care HIV testing, as compared to clients who were offered education regarding community HIV resources.	Within 3 months following visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of new HIV diagnosis	Rate of new HIV diagnosis among clients of traditional healers who were offered point-of-care HIV testing, as compared to clients who were offered education regarding community HIV resources.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linkage to HIV care at 3 months post enrollment	Rate of successful care linkage for participants with a new HIV diagnosis who received point-of-care HIV testing as compared to participants who received education regarding community HIV resources.Linkage to care will be defined as accessing outpatient care or treatment such as antiretroviral therapy (ART).	3 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute for Medical Research, Tanzania
• Investigators: Principal Investigator: Radhika Sundararajan, PhD, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2019
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 31, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 19-04020274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be made available.
• IPD Sharing Time Frame: Data will be available beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Requests should be directed to ras9199@med.cornell.edu .
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No