Innovations in HIV Testing

Study Overview
=================
Brief Summary
-----------------
The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.

Detailed Description
-----------------
The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. In this study the investigators proposed two phases. The first phase, previously completed, is formative and involved two parts: 1) conducting formative qualitative research to understand perceptions of HIV testing and HIV self-testing in the study population and 2) conducting observed HIV self-testing to better understand any challenges with self-testing and the materials needed to make the process clear. The second phase of the study is a randomized controlled trial where the investigators will randomize approximately 400 young women to receive either 1) CHOICE of self-testing or clinic-based HIV Counseling and Testing (HCT) or 2) clinic based HCT. Once young women have been randomized, they will be asked to recruit up to 4 peers or male sex partners to test with the method of their randomization group.

Official Title
-----------------
Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners

Conditions
-----------------
Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Other: Oraquick HIV Self Test
* Other: Clinic Based HIV Counseling and Testing (HCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Inclusion Criteria Index: Females ages 18-26 Have had sex in the past 3 months and plan to have sex again in the next 3 months Planning on staying in the Agincourt Health and Demographic Surveillance System (AHDSS) area for the next nine months Able and willing to provide informed consent Willing to comply with study procedures Not known to be HIV positive (not reporting a previous positive test) Eligibility Inclusion Criteria Peer/Partner: Females and Males ages 18 and older Able and willing to provide informed consent Willing to comply with study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants randomized to (1) Choice - they get to choose (1a) self-test vs (1b) HCT (HIV testing and counseling at clinic) or (2) they are randomized to HCT.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Choice<br>Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT) | Other: Oraquick HIV Self Test<br>* This is an oral swab in home HIV test.<br>Other: Clinic Based HIV Counseling and Testing (HCT)<br>* Receiving Counseling and Testing for HIV at the clinic.<br>|
| Active Comparator: HIV Counseling and Testing<br>Clinic Based HIV Counseling and Testing (HCT) | Other: Clinic Based HIV Counseling and Testing (HCT)<br>* Receiving Counseling and Testing for HIV at the clinic.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of index reporting testing uptake | Compare between the two study arms the proportion of testing uptake at 3 months post-randomization. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit. | 3 months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of peer/partner referrals by the index | Compare between the two studies arms the number of self test kits and HCT cards distributed by the index. | 12 months post randomization | 
| Proportion of peer/partners reporting testing uptake | Compare between the two study arms the proportion of testing uptake by peers/partners. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit. | 12 months post randomization | 
| Proportion of index and peer/partners who obtain a confirmatory test, start Antiretroviral Treatment (ART) if HIV+, and obtain their Cluster of Differentiation 4 (CD4) count if HIV+ | Among participants who test positive (young women, peers and sex partners), the investigators will examine uptake of linkage to care. | 12 months post randomization |