Culturally Congruent HIV Risk Reduction App for Young Women, an Acceptability & Pilot Evaluation

NCT ID: NCT02733692

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-06-30

Brief Summary

Smartphone applications and mobile technologies offer users the potential to access critical information (e.g., proper condom use, directions to testing sites, and other sexual and reproductive health services) when it is needed most. Relevant findings will identify areas where existing interventions may be leveraged and adapted to work among young women of color in an urban setting and their networks. As SRH smartphone apps continue to proliferate, this study will expand researchers', developers', and health educators' limited knowledge about the feasibility, acceptability and preliminary efficacy of a sexual health educational app tailored with and for young Black and Latino women, aged 18-25 in NYC, including whether this app acts as a gateway to sexual health educators, clinical and other service providers. If proven effective, findings from this study will identify areas where existing interventions may be leveraged and adapted to work among a YBLW and their networks, and potentially adapted for other high needs communities.

Detailed Description

New HIV, Chlamydia and Gonorrhea infections are highest among young Black women and Latinas aged 13 to 29 years old compared to White women, which negatively impacts other sexual and reproductive health outcomes. Given that young women have a substantial need for SRH services and a high smartphone ownership, unique opportunities to utilize mobile apps(applications) to decrease HIV risk behaviors may exist.

A tailored, culturally congruent, smartphone app co-developed with and for young Black and Latino women (18 to 25 years old) not yet publicly available offers a unique opportunity to conduct a feasibility, acceptability, and pilot RCT. Using this app, this pilot that will: a) assess feasibility of the sampling, consent, recruitment and retention techniques; b) collect acceptability and usability data and cultural congruence on the app; a and c) collect pilot data to test differences between intervention and control groups on the preliminary estimates of app effectiveness to inform a potential larger-scale study. The investigators propose YBLW between 18 and 25 years old in NYC will use a mobile-based health education app to access SRH education information. Additionally, those who use the tailored SRH app will have more self-reported connection to SRH services, better knowledge of SRH education domains, and how to link to clinical services (e.g., PREP, PEP, EC, birth control, HIV, STD, and pregnancy testing), compared to the control group. Analysis for the first aim will employ process measures and the second and third aims are mixed-methods aims.

Analysis will compare differences between the 2-arms and indiscernible differences and culturally tailored usability will be explored via focus groups and web analytics.

Conditions

HIV; STDs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

GURHL Code Smartphone application

Experimental arm will receive the 'Understanding Reproductive Health for Ladeez (GURHL) Code 'app' (application) for their smartphone with sexual health information. The intervention is embedded in the smart phone application. This includes sexual and reproductive health knowledge, plus access to a National Planned Parenthood health educator, and directions to other nearby clinics. Participants will be assessed using A-CASI at 3 months after enrollment.

Group Type: EXPERIMENTAL

Understanding Reproductive Health for Ladeez (GURHL) Code

Intervention Type: BEHAVIORAL

Understanding Reproductive Health for Ladeez (GURHL) Code is an acceptability study to test a web-based application designed with and for young women of color 18 to 25 years old.

Control

The control arm will receive usual care. That is, they will receive a web-based flyer. This flyer will include a list of clinics and other trusted available resources, but without hyperlinks.

Participants will be assessed using A-CASI at 3 months after enrollment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Understanding Reproductive Health for Ladeez (GURHL) Code

Understanding Reproductive Health for Ladeez (GURHL) Code is an acceptability study to test a web-based application designed with and for young women of color 18 to 25 years old.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• women between 18 and 25 years old;
• self-identify as either Black and/or Latina;
• own a smartphone (iOS or android);
• live in NYC;
• report vaginal or anal intercourse in their lifetime;
• report unprotected intercourse in their lifetime;
• healthy (not controls) adults. There will be estimated total 110 of said subjects.

Exclusion Criteria

• being married or partnered for more than one year,
• report only being sexually active with women,
• pregnant or have children 2 years old or younger,
• HIV+ status,
• men,
• individuals under 18 and over 25,
• live in a place other than New York City,
• formal training as a sexual peer health educator (beyond a high school health class) or
• unable to read English.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

City University of New York, School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis Nash, PhD

Role: STUDY_CHAIR

CUNY Graduate School of Public Health & Health Policy

Locations

CUNY

New York, New York, United States

Countries

United States

Other Identifiers

381039

Identifier Type: -

Identifier Source: org_study_id