Clinical trial NCT02733692: Culturally Congruent HIV Risk Reduction App for Young Women, an Acceptability & Pilot Evaluation
Official title: Culturally Congruent HIV Risk Reduction App for Young Women, an Acceptability & Pilot Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
STDs
Keywords: HIV
STDs
web-based app
women
Lead sponsor: City University of New York, School of Public Health
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Preliminary Efficacy1 Improvement in Sexual Health Knowledge Condom Use
timeFrame: 3 months
measure: Preliminary Efficacy 2 Improvement in Sexual Health Knowledge Sexual and Reproductive Health Services
timeFrame: 3 months
measure: Preliminary Efficacy 2 Improvement in Sexual Health Knowledge HIV and STD
timeFrame: 3 months
measure: Preliminary Efficacy 3 Improvement in Sexual Health Knowledge Connection to Services
timeFrame: 3 months
Secondary outcomes:
measure: Usability 1 Number of Times Used
timeFrame: 3 months
measure: Usability 2 Actions Taken
timeFrame: 3 months
measure: Usability 3 Duration
timeFrame: 3 months
measure: Usability 4A App performance
timeFrame: 3 months
measure: Usability 4B Ease of App usage
timeFrame: 3 months
measure: Usability 5 Facilitators and Barriers
timeFrame: 3 months
measure: Usability 6 User Friendliness
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: CUNY
state: New York
Study officials:
affiliation: CUNY Graduate School of Public Health & Health Policy
name: Denis Nash, PhD
role: STUDY_CHAIR
References: