Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers
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|ClinicalTrials.gov Identifier: NCT03718871|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Health Behaviors||Behavioral: HIV testing at traditional healer practices||Not Applicable|
This study has three specific aims:
Specific Aim 1: Identify key socio-structural factors that frame HIV testing behaviors among clients of Ugandan TH, using an exploratory sequential, mixed-methods study design. First, qualitative interviews with 25-35 purposely-sampled TH clients will characterize the care-seeking trajectory, HIV testing behaviors and related stigma, healthcare costs, and HIV risks and exposures. Based on these results, a survey will be designed and administered to 300 Ugandan adults who utilize TH in Mbarara District. This cross-sectional study will identify 1) rates of HIV testing among TH clients and 2) variables that independently predict HIV testing within the prior 12 months. These data will inform a model of HIV testing behavior among TH clients based on the Andersen Model of Healthcare Utilization, and generate hypotheses to be tested in Specific Aim 2.
Specific Aim 2: Characterize acceptability of receiving point-of-care (POC) HIV testing at TH locations, using an exploratory sequential, mixed-methods approach. Qualitative interviews with 15-25 purposely sampled TH and 15-25 purposely-sampled TH clients will explore attitudes and experiences with biomedicine, feasibility and acceptability of delivering POC HIV testing at TH locations, and investigate relevant themes emerging from Aim 1. Based on qualitative results, a survey will be developed and administered to 175 TH in Mbarara District. This cross-sectional study will characterize TH practices relevant to HIV testing, and identify characteristics of healers who favorably view the proposed intervention (Specific Aim 3). These data will be integrated with results from SA1 to develop an intervention that will overcome socio-structural barriers to HIV testing.
Specific Aim 3: Develop and pilot an HIV testing intervention among TH clients. Integration of results from SA1 and SA2 will inform a pilot HIV testing intervention at 10 TH practice locations, to be compared with a control group receiving usual TH care. This pilot will offer HIV testing at TH practice sites to 250 TH clients. Primary outcome for this study will be rates of HIV testing among TH clients. Secondary outcomes will include i) number of new HIV diagnoses among TH clients, ii) socio-demographic factors that predict HIV testing, and iii) percentage of patients with +HIV POC test who successfully link to HIV care in 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a mixed methods study where Aims 1 and 2 have both qualitative and quantitative arms. Aim 3 is an unblinded intervention, with a control arm (Sept 2019-June 2020).|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Healer HIV testing intervention
We will follow Ugandan National protocols to administer voluntary HIV testing at 5 TH practice locations throughout Mbarara District over a 9 month period.
Behavioral: HIV testing at traditional healer practices
HIV 1/2 antigen-antibody POC test (Alere Determine©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered. Clients with positive tests will be provided with detailed contact information for the MUST ISS clinic, and given specific instructions to present to the clinic as soon as possible for Western Blot confirmation, and linkage to care.
No Intervention: Healer control arm
Patients will undergo usual TH care. After the session, the TH will inform study staff if the client was referred for VCT. Study staff will contact the client once per month, for 3 months, to assess for VCT since enrollment in the study.
- Rate of HIV testing among TH clients [ Time Frame: within 3 months following visit ]
- new HIV diagnoses among TH clients [ Time Frame: within 3 months ]
- patients with +HIV test who successfully link to HIV care [ Time Frame: within 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718871
|Contact: Radhika Sundararajan, MD, PhDfirstname.lastname@example.org|
|Contact: Juliet Mwanga-Amumpaire, MD||+256 email@example.com|
|Mbarara University of Science and Technology||Recruiting|
|Contact: Juliet Mwanga-Amumpaire, MD (+256) 772 721 751|
|Contact: Donny Ndazima, MS|
|Principal Investigator:||Radhika Sundararajan, MD, PhD||Weill Medical College of Cornell University|