Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
56 participants
INTERVENTIONAL
2022-02-05
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to refine and test a mobile HIV Prevention and Reproductive Health app developed specifically for Black women.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implementation of Rapid HIV Self-Testing Among MSM Project
NCT04219878
PrEP US NoW: PrEP Utilization Through Increasing Social Capital Among YBMSM Networks With Women
NCT07024745
Feasibility, Acceptability, and Preliminary Efficacy of an HIV Prevention Intervention for Older Black Women
NCT07181616
Multi-component Intervention to Train Providers to Promote PrEP for Girls and Women in the Deep South
NCT06487390
Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color
NCT04018651
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Preliminary data obtained from a Community Advisory Board (CAB), which will consist predominately of Black women will guide refinement of the content and features included within the mobile app, whilst ensuring that the app is tailored towards the needs and perspectives of Black women.
This will be a randomized study with quantitative data collected through surveys, and qualitative data collected through in-depth interviews.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
in-the-kNOW mobile app.
Participants will be assigned to the in-the-kNOW mobile app for four (4) months.
in-the-kNOW mobile app
in-the-kNOW is a mobile app with restricted access through a single-use registration code.
The app will be developed with regular input from Black women enrolled in Atlanta Healthy Start Initiative (AHSI).
The app will have culturally- and contextually targeted HIV prevention and optimal sexual health messaging.
Each participant will have 4 months to engage with the app, with e-reminders in time intervals preferred by the participants (a minimum of 3 times per week) via push notifications. During the 4-month study period, participants will receive push notifications to encourage the use of all app domains: My Logger, My Test, My Resources, and My Circle.
Research staff will complete 2-month check-ins via phone call or video chat with participants.
Control condition.
Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider.
Control
The control condition will be a one-time virtual women's health counseling session with a healthcare provider. Participants will get information on
1. Sexual Transmitted Infections (STI)/HIV prevention,
2. Family planning, and
3. General health promotion (e.g., exercise and diet).
The control condition provides access to HIV prevention materials that are publicly available but that do not offer the dynamic and individually customized features of the health communication/new media research approach proposed herein.
Control group participants will continue to receive the usual care associated with Atlanta Healthy Start Initiative (AHSI) enrollment.
The control group will not have access to intervention content (e.g. commodity ordering) until after the study has concluded.
Research staff will complete 2-month check-ins via phone call or video chat with participants.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
in-the-kNOW mobile app
in-the-kNOW is a mobile app with restricted access through a single-use registration code.
The app will be developed with regular input from Black women enrolled in Atlanta Healthy Start Initiative (AHSI).
The app will have culturally- and contextually targeted HIV prevention and optimal sexual health messaging.
Each participant will have 4 months to engage with the app, with e-reminders in time intervals preferred by the participants (a minimum of 3 times per week) via push notifications. During the 4-month study period, participants will receive push notifications to encourage the use of all app domains: My Logger, My Test, My Resources, and My Circle.
Research staff will complete 2-month check-ins via phone call or video chat with participants.
Control
The control condition will be a one-time virtual women's health counseling session with a healthcare provider. Participants will get information on
1. Sexual Transmitted Infections (STI)/HIV prevention,
2. Family planning, and
3. General health promotion (e.g., exercise and diet).
The control condition provides access to HIV prevention materials that are publicly available but that do not offer the dynamic and individually customized features of the health communication/new media research approach proposed herein.
Control group participants will continue to receive the usual care associated with Atlanta Healthy Start Initiative (AHSI) enrollment.
The control group will not have access to intervention content (e.g. commodity ordering) until after the study has concluded.
Research staff will complete 2-month check-ins via phone call or video chat with participants.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Self-identify as Black
* Assigned female at birth and identify as female;
* Individuals who qualify for Pre-Exposure Prophylaxis (PrEP) based on the Centers for Disease Control (CDC) criteria (for residence in high HIV incident areas-reside in Fulton, Cobb, Gwinnett, or Dekalb counties)
* Sexually active within the last 6 months
* HIV-negative
* Owner of an Android or IOS smartphone
Exclusion Criteria
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Cognitively impaired or Individuals with Impaired Decision-Making Capacity
* Individuals who are not able to clearly understand English
18 Years
44 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Morehouse School of Medicine
OTHER
Georgia Institute of Technology
OTHER
National Institute of Mental Health (NIMH)
NIH
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rasheeta Chandler
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rasheeta Chandler, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Nell Hodgson School of Nursing, Emory University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Black Women's Wellness
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00002857
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.