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

NCT02733692 | Completed DMC

• 1 other identifier: 381039
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; STDs

Keywords

HIV; STDs; web-based app; women

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• Usability 1 Number of Times Used

  3 months

• Usability 2 Actions Taken

  3 months

• Usability 3 Duration

  3 months

• Usability 4A App performance

  3 months

• Usability 4B Ease of App usage

  3 months

Study Arms (2)

GURHL Code Smartphone application

EXPERIMENTAL

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.

Behavioral: Understanding Reproductive Health for Ladeez (GURHL) Code

Control

NO INTERVENTION

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.

Interventions

Understanding Reproductive Health for Ladeez (GURHL) Code 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.

GURHL Code Smartphone application

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• City University of New York, School of Public Health: lead

Study Sites (1)

CUNY

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Clinical Coding

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Forms and Records Control; Office Management; Practice Management; Professional Practice; Organization and Administration; Health Services Administration; Medical Records; Records; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Methods; Public Health; Environment and Public Health

Study Officials

• Denis Nash, PhD

  CUNY Graduate School of Public Health & Health Policy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: April 11, 2016
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 25, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)