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

NCT ID: NCT04071873

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2020-10-01

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.

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..

Conditions

HIV; Health Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Point-of-care HIV testing (intervention)

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

Group Type: EXPERIMENTAL

Point-of-care HIV testing

Intervention Type: 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.

Education on community HIV resources (control)

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

Group Type: ACTIVE_COMPARATOR

HIV testing education

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

HIV testing education

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Radhika Sundararajan, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

National Institute for Medical Research

Mwanza, , Tanzania

Countries

Tanzania

Other Identifiers

19-04020274

Identifier Type: -

Identifier Source: org_study_id