Clinical trial NCT02965014: NC Young Women's CoOp
Official title: Young Women-Focused HIV Prevention: Seek & Test in North Carolina (NC) Clinics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Condomless Sex
Human Immunodeficiency Virus (HIV)
Sexually Transmitted Infection (STI)
Alcohol and Drug Use
Keywords: Human Immunodeficiency Virus (HIV)
Sexually transmitted infections (STI)
mHealth
Substance abuse
Violence
Victimization
Sexual Risk
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Durham County Department of Public Health
name: Guilford County Department of Public Health
name: Wake County Human Services
First posted: 2016-11-16
Enrollment: 652
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This three-arm cross-over randomized trial will develop, test, and compare the efficacy of two delivery formats of the Young Women's CoOp (YWC), which is designed to provide risk reduction and empowerment skills, as well as linkages to healthcare services for women who use substances. The current study will develop a revised version of the YWC and evaluate the relative efficacy of a face-to-face (face-to-face YWC), mobile Health application (mHealth YWC) delivery format, and HIV counseling and testing (HCT) as a control to reduce risky sexual behaviors and reduce substance use among young (18-25) African American women who use substances and are sexually active and have not recently been tested for HIV in three NC counties.

Detailed description: The purpose of this study is to use the seek, test, treat, and retain framework to develop and test the efficacy of a clinic-based, age-appropriate, woman-focused HIV risk-reduction intervention to reduce sexual risk among up to 700 young sexually active African American women aged 18 to 25 who use drugs in three North Carolina counties. The researchers will test the delivery of the woman-focused intervention conducted in two formats, face-to-face YWC and mHealth YWC, using a three-arm cross-over randomized design in which counties are randomized to (1) HCT as the control, (2) face-to-face YWC; and (3) mHealth YWC that will be delivered on tablets using an interactive app. The researchers will fulfill the purpose of this study through the following aims: (Aim 1) To develop a new YWC intervention and recruitment strategies using formative methods to engage young African American women who use substances and have not recently been tested for HIV, clinic staff, and stakeholders to ensure age appropriateness, to identify barriers to reaching these young women and the challenges in conducting the intervention in the clinics, and to develop the mHealth YWC; (Aim 2) To test the efficacy of two formats of the woman-focused intervention program (face-to-face YWC and mHealth YWC) relative to HCT with up to 700 young women aged 18 to 25 in three North Carolina county health departments for primary outcomes at 6-, and 12-month follow-up assessments; (Aim 3) To estimate the total costs of implementing the face-to-face YWC and mHealth YWC interventions, and to assess the resource components that drive these costs; and (Aim 4) To examine the extent to which the face-to-face YWC and mHealth YWC are perceived by collaborating health clinic staff and participants as being acceptable and sustainable.

Eligibility criteria: Selected Inclusion Criteria:

* Identify as female
* Identify as Black or African American
* 18-25 years of age
* Have used alcohol or drugs in greater quantity or for a longer period of time than intended within the past 30 days

Exclusion Criteria:

* Participants may not be non-Black/African American

Primary outcomes:
measure: Condomless Sex
timeFrame: Baseline
measure: Condomless Sex
timeFrame: 6-month follow-up
measure: Condomless Sex
timeFrame: 12-month follow-up
measure: Frequency of Substance Use
timeFrame: Baseline
measure: Frequency of Substance Use
timeFrame: 6-month follow-up
measure: Frequency of Substance Use
timeFrame: 12-month follow-up
Secondary outcomes:
measure: Increased Sexual Negotiation
timeFrame: Baseline
measure: Increased Sexual Negotiation
timeFrame: 6-month follow-up
measure: Increased Sexual Negotiation
timeFrame: 12-month follow-up
measure: Reduced Alcohol and Illicit Drug Use for a Subsample of Participants
timeFrame: Baseline
measure: Reduced Alcohol and Illicit Drug Use for a Subsample of Participants
timeFrame: 6-month follow-up
measure: Reduced Alcohol and Illicit Drug Use for a Subsample of Participants
timeFrame: 12-month follow-up
measure: Reduced Violence and Victimization for a Subsample of Participants
timeFrame: Baseline
measure: Reduced Violence and Victimization for a Subsample of Participants
timeFrame: 6-month follow-up
measure: Reduced Violence and Victimization for a Subsample of Participants
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham County Department of Public Health
state: North Carolina
city: Greensboro
country: United States
facility: Guilford County Department of Public Health - Greensboro
state: North Carolina
city: High Point
country: United States
facility: Guilford County Department of Public Health - High Point
state: North Carolina
city: Raleigh
country: United States
facility: Wake County Human Services
state: North Carolina
Study officials:
affiliation: RTI International
name: Felicia Browne, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Browne FA, Washio Y, Zule WA, Wechsberg WM. HIV-related risk among justice-involved young African American women in the U.S. South. Health Justice. 2023 Aug 24;11(1):32. doi: 10.1186/s40352-023-00228-7.
citation: Osakwe CE, van der Drift I, Opper CA, Zule WA, Browne FA, Wechsberg WM. Condom Use at Last Sex and Sexual Negotiation Among Young African American Women in North Carolina: Context or Personal Agency. J Racial Ethn Health Disparities. 2024 Aug;11(4):2256-2264. doi: 10.1007/s40615-023-01693-4. Epub 2023 Jul 26.
citation: Watkins RL, Browne FA, Kizakevich PN, Howard BN, Turner LB, Eckhoff R, Wechsberg WM. An Evidence-Based HIV Risk-Reduction Intervention for Young African American Women in the US South Using mHealth: Adaptation and Development Study. JMIR Form Res. 2022 May 9;6(5):e34041. doi: 10.2196/34041.
citation: Browne FA, Wechsberg WM, Kizakevich PN, Zule WA, Bonner CP, Madison AN, Howard BN, Turner LB. mHealth versus face-to-face: study protocol for a randomized trial to test a gender-focused intervention for young African American women at risk for HIV in North Carolina. BMC Public Health. 2018 Aug 6;18(1):982. doi: 10.1186/s12889-018-5796-8.