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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733692
• Other study ID #: 381039
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: August 24, 2017
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2017
• Source: City University of New York, School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• STDs

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	CUNY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
City University of New York, School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary Efficacy1 Improvement in Sexual Health Knowledge Condom Use	Effectiveness of the app based on reported knowledge of where to get condoms and how to use properly.	3 months
Primary	Preliminary Efficacy 2 Improvement in Sexual Health Knowledge Sexual and Reproductive Health Services	Effectiveness of the app based on reported knowledge of what sexual and reproductive health services exist and where to access them	3 months
Primary	Preliminary Efficacy 2 Improvement in Sexual Health Knowledge HIV and STD	Effectiveness of the app based on reported knowledge of what behaviors increase the risk for HIV and other sexually transmitted diseases	3 months
Primary	Preliminary Efficacy 3 Improvement in Sexual Health Knowledge Connection to Services	Effectiveness of the app based on reported knowledge of connection to sexual and reproductive health clinical services, based on whether women communicated with a reproductive health educator and whether she sought sexual and reproductive health services in person.	3 months
Secondary	Usability 1 Number of Times Used	The usability of the app will be determined by the number of times the app is opened	3 months
Secondary	Usability 2 Actions Taken	The usability of the app will be determined by the actions users take during sessions (each action coded as positive regardless of which one, including other links clicked on, audio listened to or video links clicked on)	3 months
Secondary	Usability 3 Duration	The usability of the app will be determined by the duration of page visits	3 months
Secondary	Usability 4A App performance	The usability of the app will be determined by the number of technical errors encountered by users.	3 months
Secondary	Usability 4B Ease of App usage	The usability of the app will be determined by the ease of usage and if users liked and understood the contents	3 months
Secondary	Usability 5 Facilitators and Barriers	The usability of the app will be determined by user reports of facilitators and barriers to usage.	3 months
Secondary	Usability 6 User Friendliness	The usability of the app will be determined by the users' assessment of usefulness, trustworthiness and usability	3 months