HIVNCT02733692
Culturally Congruent HIV Risk Reduction App for Young Women, an Acceptability & Pilot Evaluation
A study testing Understanding Reproductive Health for Ladeez (GURHL) Code in people with HIV and STDs, run by City University of New York, School of Public Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- What is being tested?
- Understanding Reproductive Health for Ladeez (GURHL) Code
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Understanding Reproductive Health for Ladeez (GURHL) Code
- Keywords
- HIV, STDs, web-based app, women
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Understanding Reproductive Health for Ladeez (GURHL) CodeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 3 months
Secondary outcomes (7)
Usability 1 Number of Times Used
The usability of the app will be determined by the number of times the app is opened
Measured: 3 months
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)
Measured: 3 months
Usability 3 Duration
The usability of the app will be determined by the duration of page visits
Measured: 3 months
Usability 4A App performance
The usability of the app will be determined by the number of technical errors encountered by users.
Measured: 3 months
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
Measured: 3 months
Usability 5 Facilitators and Barriers
The usability of the app will be determined by user reports of facilitators and barriers to usage.
Measured: 3 months
Usability 6 User Friendliness
The usability of the app will be determined by the users' assessment of usefulness, trustworthiness and usability
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- City University of New York, School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Nash, PhD, Study chair, CUNY Graduate School of Public Health & Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733692
- Sponsor's protocol ID
- 381039
- Status last verified
- Jul 2017
- First submitted
- 11 Jan 2016
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The data collected and used ofr this will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Congruent HIV Risk Reduction App for Young Women, an Acceptability & Pilot Evaluation
- ClinicalTrials.gov ID
- NCT02733692
- Acronym / sponsor ID
- 381039
- Keywords
- HIV, STDs, web-based app, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- City University of New York, School of Public HealthUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GURHL Code Smartphone application | Experimental | Behavioral: Understanding Reproductive Health for Ladeez (GURHL) CodeExperimental 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. |
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Understanding Reproductive Health for Ladeez (GURHL) CodeUnderstanding 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. | Behavioural | GURHL Code Smartphone application |
Primary outcome
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.
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
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
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.
7 secondary outcomes
Usability 1 Number of Times Used
Time frame: 3 months
Usability 2 Actions Taken
Time frame: 3 months
Usability 3 Duration
Time frame: 3 months
Usability 4A App performance
Time frame: 3 months
Usability 4B Ease of App usage
Time frame: 3 months
Usability 5 Facilitators and Barriers
Time frame: 3 months
Usability 6 User Friendliness
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Individual participant dataSharing planned: No. The data collected and used ofr this will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Nash, PhD study chair
CUNY Graduate School of Public Health & Health Policy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Understanding Reproductive Health for Ladeez (GURHL) Code in people with HIV and STDs, run by City University of New York, School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary Efficacy1 Improvement in Sexual Health Knowledge Condom Use (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.