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

August 24, 2017 updated by: City University of New York, School of Public Health
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10027
        • CUNY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preliminary Efficacy1 Improvement in Sexual Health Knowledge Condom Use
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usability 1 Number of Times Used
Time Frame: 3 months
The usability of the app will be determined by the number of times the app is opened
3 months
Usability 2 Actions Taken
Time Frame: 3 months
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
Usability 3 Duration
Time Frame: 3 months
The usability of the app will be determined by the duration of page visits
3 months
Usability 4A App performance
Time Frame: 3 months
The usability of the app will be determined by the number of technical errors encountered by users.
3 months
Usability 4B Ease of App usage
Time Frame: 3 months
The usability of the app will be determined by the ease of usage and if users liked and understood the contents
3 months
Usability 5 Facilitators and Barriers
Time Frame: 3 months
The usability of the app will be determined by user reports of facilitators and barriers to usage.
3 months
Usability 6 User Friendliness
Time Frame: 3 months
The usability of the app will be determined by the users' assessment of usefulness, trustworthiness and usability
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City University of New York, School of Public Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Denis Nash, PhD, CUNY Graduate School of Public Health & Health Policy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 381039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data collected and used ofr this will not be made publicly available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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