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

NCT04071873 | Completed

• 1 other identifier: 19-04020274
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Health Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of new HIV diagnosis

  3 months

Other Outcomes (1)

• Linkage to HIV care at 3 months post enrollment

  3 months

Study Arms (2)

Point-of-care HIV testing (intervention)

EXPERIMENTAL

Participants will be offered voluntary point-of-care HIV testing during a traditional healer visit.

Diagnostic Test: Point-of-care HIV testing

Education on community HIV resources (control)

ACTIVE COMPARATOR

Participants will be offered education regarding HIV testing and community resources during a traditional healer visit.

Behavioral: HIV testing education

Interventions

Point-of-care HIV testing DIAGNOSTIC_TEST

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.

Point-of-care HIV testing (intervention)

HIV testing education BEHAVIORAL

Participants will be provided with education on community based HIV resources.

Education on community HIV resources (control)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• less than 18 years of age
• Known to be HIV-infected
• Unable to provide informed consent
• Unwilling to participate in follow-up
• Unwilling to have point-of-care HIV test
• Unwilling to receive the results of HIV test

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute for Medical Research, Tanzania: collaborator

Study Sites (1)

National Institute for Medical Research

Mwanza, Tanzania

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Radhika Sundararajan, PhD, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: October 14, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication.
• Access Criteria: Requests should be directed to ras9199@med.cornell.edu .

Locations

TA (1)