Improving Prevention Systems to Reduce Disparities for High Priority Populations

Study Overview
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Brief Summary
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This project collaborates with the New York City Department of Health and Mental Hygiene (NYC DOHMH) to develop and test a field-based comprehensive sexual health intervention for HIV-exposed contacts notified by its Partner Services (i.e., HIV contact tracing) program. The goal of the study is to develop and test the impact of this new intervention on improving rates of HIV testing, linkage to HIV prevention/care, and PrEP uptake among highest risk contacts recently exposed to HIV. We will conduct a 6-month pilot project, followed by a cross-sectional stepped wedge cluster randomized trial in which 12 clusters of NYC neighborhoods are exposed to the intervention sequentially, with three clusters moving from control to intervention every 6 months (n = 1150). Primary outcomes are HIV testing, timely PrEP/ARV uptake, and linkage to PrEP/HIV care. Secondary outcomes are STD testing and receipt of STD treatment (if indicated).

Official Title
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Improving Prevention Systems to Reduce Disparities for High Priority Populations

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Fast Track Partner Services-Sexual Health Intervention
* Other: Partner Services Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Contacts referred to the Partner Services program during the study time period Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study uses a cross sectional stepped wedge cluster randomized design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast Track Intervention<br>This arm refers to the new Partner Services-Sexual Health intervention offered to contacts by the Partner Services program | Other: Fast Track Partner Services-Sexual Health Intervention<br>* The Partner Services-Sexual Health Intervention enhances the current standard of care by introducing four service innovations to the DOHMH Partner Services program: (1) enhanced field-based combination HIV and STI testing; (2) immediate field-based ARV/PrEP start; (3) navigation to a sexual health clinic for test results and treatment; and (4) enhanced linkage support to facilitate ongoing PrEP or HIV care.<br>|
| Active Comparator: Standard of Care<br>This arm refers to the current standard practice for partners contacted by the Partner Services program | Other: Partner Services Standard of Care<br>* Participants in neighborhoods that have not yet been assigned to the intervention condition in the stepped wedge trial will receive standard Partner Services components, including field-based HIV testing and referral to clinical sites for HIV prevention or treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of HIV Testing | Whether or not contacts offered testing by the Partner Services program accept HIV testing | 1 month | 
| PrEP/ARV Initiation | Whether or not contacts start ARV medication in the field or at their referral visit | 3 months | 
| Linkage to PrEP/HIV Care | Whether or not contacts attend their navigation visit to receive ongoing PrEP or HIV services | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STI testing | Whether or not contacts accept STI testing in the field or at their referral visit | 3 months |