Mobile HIV Prevention App for Black Women

NCT05080972 | Completed Results

• 3 other identifiers: STUDY000028571R34MH128048-012024P007523
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Black women have a significantly higher risk of acquiring HIV compared to their non-Black counterparts. The purpose of this study is to refine and test a mobile HIV Prevention and Reproductive Health app developed specifically for Black women.

Conditions

Mobile Phone Use; Hiv; Stigma, Social

Outcome Measures

Primary Outcomes (6)

• Retention Rate

  Feasibility is assessed with the retention rate of participants in each study arm. Quantitative survey and qualitative interview data to determine acceptability of both the mobile app and the control condition.

  4 months

• App User Retention Rate

  App user retention rate was calculated among participants only in the intervention group. App user retention was measured by comparing the number of first-time app opens to the number of app removals.

  4 months

• System Usability Scale (SUS)

  The System Usability Scale (SUS) is a validated industry-standard scale used to evaluate a variety of products and services, including websites, mobile phones, computer software, and more. It is a quick, 10-item questionnaire for gauging perceived usability, resulting in a score from 0-100, where higher is better, with 68 as the average benchmark, and scores above 80 considered excellent; it's calculated by summing adjusted responses to positive/negative statements. Lower scores indicate low usability, and higher scores indicate good usability. \*Only participants in the treatment group received these questions.

  4 months

• Impact Scale

  Impact is evaluated using three items that assess how the SavvyHER app influences Black women's quality of life and their sexual and reproductive health. Items prompt participants to rate their agreement with statements such as "I think SavvyHER will be a positive addition to sexual and reproductive health resources for Black women" and "I think SavvyHER will improve the Quality of Life for Black women," with responses on a scale from "strongly disagree" (1) to "strongly agree" (5). Scores were calculated by averaging the responses. Impact scores ranged from 1 to 5, where 1 indicates the least perceived impact, and 5 indicates the most positive perceived impact. A high impact score indicates that the users perceive the technology as having a strong, positive, real-world effect on their relevant outcomes or performance. Higher scores indicate that the mHealth app had a more positive impact on their quality of life and health.

  4 months

• Perceived Usefulness (PU) Scale

  Perceived usefulness (PU) is defined as the extent to which a person believes that using a system or tool will help in reaching their goals. The PU of SavvyHER was determined from participants' responses to nine survey items assessing the app's impact on their quality of life and health management. Survey items used 5-point Likert scales, ranging from "strongly disagree" (1) to "strongly agree" (5). These scores are calculated by averaging the responses across PU items. PU scores ranged from 1 to 5, with higher scores indicating a more positive perception of the technology being evaluated.

  4 months

• Perceived Ease of Use (PEOU) Scale

  Perceived ease of use (PEOU) is the extent to which a system or tool is easy to learn and use. PEOU is assessed using five survey items rated on a 5-point Likert scale that ask about people's experiences learning to operate a technological system or tool. Sample items prompt participants to rate their agreement with statements such as "Learning to operate SavvyHER is easy for me" and "It is easy for me to become skillful at using SavvyHER," with responses on a scale from "strongly disagree" (1) to "strongly agree" (5). Scores were calculated by averaging responses across PEOU items. PEOU scores ranged from 1 to 5, with higher scores indicating that users find the system intuitive. A high PEOU score suggests that users find the system intuitive.

  4 months

Secondary Outcomes (6)

• Number of Home Test Kits Ordered by Participants.

  4 months

• Number of Participants Indicating Intention to Start PrEP

  4 months

• Number of Participants Who Agreed With Statements About PrEP Initiation

  4 months

• Number of Participant's Who Initiated PrEP Treatment

  4 months

• Number of Enrolled Participants by Recruiting Source

  4 months

Other Outcomes (3)

• Amount of App Interactions

  1 month

• The Elapsed Time From First Contact to Enrollment

  4 months

• Technological Challenges or Other Connection Challenges.

  4 months

Study Arms (2)

in-the-kNOW mobile app.

EXPERIMENTAL

Participants will be assigned to the in-the-kNOW mobile app for four (4) months.

Behavioral: in-the-kNOW mobile app

Control condition.

ACTIVE COMPARATOR

Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider.

Behavioral: Control

Interventions

in-the-kNOW mobile app BEHAVIORAL

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.

Also known as: in-the-kNOW mobile health app

in-the-kNOW mobile app.

Control BEHAVIORAL

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.

Also known as: Regular Care

Control condition.

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Assigned female at birth and identify as female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• 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 incidence 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

You may not qualify if:

• Adults unable to consent
• 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

Sponsors & Collaborators

• Emory University: lead
• Morehouse School of Medicine: collaborator
• Georgia Institute of Technology: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Black Women's Wellness

Atlanta, Georgia, 30312, United States

Location

MeSH Terms

Conditions

Cell Phone Use; Acquired Immunodeficiency Syndrome; Social Stigma

Condition Hierarchy (Ancestors)

Communication; Behavior; Social Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Rasheeta Chandler, PhD, RN, FNP-BC, FAANP, FAAN
• Organization: Emory University

r.d.chandler@emory.edu

404-727-8164

Study Officials

• Rasheeta Chandler, PhD, RN

  Nell Hodgson School of Nursing, Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 18, 2021
• Study Start: February 5, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 16, 2026
• Results First Posted: March 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Locations

US (1)