Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483854
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Brief Title:
Healer-initiated HIV Counseling and Testing Versus Standard of Care in Rural South Africa
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Know Your Status A Cluster Randomized Controlled Trial Comparing Healer-initiated HIV Counseling and Testing to Standard of Care in Rural South Africa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
South Africa has made progress towards their 95-95-95 goals yet a substantial proportion of the population do not test regularly To reach people who otherwise may avoid testing we propose to build on our successful healer-initiated HIV counseling and testing pilot to conduct a cluster randomized controlled trial in 42 clinical catchment areas to evaluate an expanded Healer-Initiated HIV Testing and Linkage to Care intervention in rural South Africa
Detailed Description:
South Africa has made progress towards their 95-95-95 goals yet a substantial proportion of the population do not test regularly In South Africa people of low socioeconomic status men people in rural areas and those who distrust the health system have higher rates of HIV stigma and are less likely to receive an HIV test These individuals are also more likely to see a traditional healer for their health care needs making healers an ideal group to bridge the health care utilization divide
To reach people who otherwise may avoid testing the team trained 15 traditional healers to conduct HIV counseling and testing in their own clinics- a hut or room by their home where they provide care to their patients R34MH122259-01 Over six-months with no advertisement or community events healers offered HIV counseling and testing to 463 individuals who visited them for unrelated services Fifty-four 117 self-reported a positive HIV status Of the 409 eligible participants 316 77 agreed to test and 20 63 tested positive- 95 were linked to HIV care and treatment services
In collaboration with the Department of Health and the healers organization this study will build on a successful pilot to test an expanded Healer-Initiated HIV Testing and Linkage to Care intervention with the following testing and linkage to care components Healers will provide three testing services 1 Advertise the availability of free healer-initiated counseling and testing for their clients 2 Offer partner-based testing services at their facilities or client homes and 3 Provide monthly community-based testing outreach activities at local events eg sporting events fairs In addition to testing healers will support linkage to care and treatment adherence offering clients accompaniment to their first clinical appointment ongoing adherence supportcounseling in person or via WhatsApp and a nursecommunity health workerhealer WhatsApp group to facilitate more technical support if needed This is a cluster randomized controlled trial comparing standard of care SOC testing options vs SOC enhanced testing with support of traditional healers at 42 clinical catchment areas to evaluate the impact this intervention
The Specific Aims of this study are to 1 Compare rates of HIV testing in healer-initiated HIV counseling and testing communities vs control communities via a cluster randomized controlled trial in rural South Africa 2 Assess adoption implementation fidelity and maintenance of healer-initiated HIV testing and 3 Evaluate the cost-effectiveness of healer-initiated HIV counseling and testing compared to standard of care This team has a proven record of engaging traditional healers to improve patient outcomes conducting research to evaluate and address mistrust in the health system HIV stigma and developing interventions to increase HIV testing uptake Traditional healers are an untapped resource with the potential to reach those who historically avoid HIV testing and they have the potential to help South Africa reach their 95 testing targets
To reach people who otherwise may avoid testing the team trained 15 traditional healers to conduct HIV counseling and testing in their own clinics- a hut or room by their home where they provide care to their patients R34MH122259-01 Over six-months with no advertisement or community events healers offered HIV counseling and testing to 463 individuals who visited them for unrelated services Fifty-four 117 self-reported a positive HIV status Of the 409 eligible participants 316 77 agreed to test and 20 63 tested positive- 95 were linked to HIV care and treatment services
In collaboration with the Department of Health and the healers organization this study will build on a successful pilot to test an expanded Healer-Initiated HIV Testing and Linkage to Care intervention with the following testing and linkage to care components Healers will provide three testing services 1 Advertise the availability of free healer-initiated counseling and testing for their clients 2 Offer partner-based testing services at their facilities or client homes and 3 Provide monthly community-based testing outreach activities at local events eg sporting events fairs In addition to testing healers will support linkage to care and treatment adherence offering clients accompaniment to their first clinical appointment ongoing adherence supportcounseling in person or via WhatsApp and a nursecommunity health workerhealer WhatsApp group to facilitate more technical support if needed This is a cluster randomized controlled trial comparing standard of care SOC testing options vs SOC enhanced testing with support of traditional healers at 42 clinical catchment areas to evaluate the impact this intervention
The Specific Aims of this study are to 1 Compare rates of HIV testing in healer-initiated HIV counseling and testing communities vs control communities via a cluster randomized controlled trial in rural South Africa 2 Assess adoption implementation fidelity and maintenance of healer-initiated HIV testing and 3 Evaluate the cost-effectiveness of healer-initiated HIV counseling and testing compared to standard of care This team has a proven record of engaging traditional healers to improve patient outcomes conducting research to evaluate and address mistrust in the health system HIV stigma and developing interventions to increase HIV testing uptake Traditional healers are an untapped resource with the potential to reach those who historically avoid HIV testing and they have the potential to help South Africa reach their 95 testing targets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None