Clinical trial NCT04071873: A Novel Approach to Community-based HIV Testing With Traditional Healers in Mwanza, Tanzania
Official title: A Novel Approach to Community-based HIV Testing With Traditional Healers in Mwanza, Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Health Behavior
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research, Tanzania
First posted: 2019-08-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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..

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

Primary outcomes:
measure: Rate of HIV testing
timeFrame: Within 3 months following visit
Secondary outcomes:
measure: Rate of new HIV diagnosis
timeFrame: 3 months
Other outcomes:
measure: Linkage to HIV care at 3 months post enrollment
timeFrame: 3 months
Locations:
city: Mwanza
country: Tanzania
facility: National Institute for Medical Research
Study officials:
affiliation: Weill Medical College of Cornell University
name: Radhika Sundararajan, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: