NCT05080972: In-the-kNOW

Mobile HIV Prevention App for Black Women

Completed NA Results posted Last updated 16 March 2026

What this trial tests

NA trial testing in-the-kNOW mobile app in Mobile Phone Use in 56 participants. Completed in 31 December 2024.

Timeline

5 February 2022

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	56
Start date	5 February 2022
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

• in-the-kNOW mobile app
• Control

Conditions studied

• Mobile Phone Use — all drugs for Mobile Phone Use →
• Hiv — all drugs for Hiv →
• Stigma, Social — all drugs for Stigma, Social →

Sponsor

Emory University

Who can join

Adults 18 to 44, female only, with Mobile Phone Use or Hiv. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Retention Rate Primary · 4 months

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.

Group	Value	95% CI
In-the-kNOW Mobile App.	20
Control Condition.	24

App User Retention Rate Primary · 4 months

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.

Group	Value	95% CI
In-the-kNOW Mobile App.	70.03

System Usability Scale (SUS) Primary · 4 months

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 recei

Group	Value	95% CI
In-the-kNOW Mobile App.	63.25	± 13.54

Impact Scale Primary · 4 months

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

Group	Value	95% CI
In-the-kNOW Mobile App.	4.19	± 0.71

Perceived Usefulness (PU) Scale Primary · 4 months

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.

Group	Value	95% CI
In-the-kNOW Mobile App.	3.54	± 0.63

Perceived Ease of Use (PEOU) Scale Primary · 4 months

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 scor

Group	Value	95% CI
In-the-kNOW Mobile App.	3.69	± 0.58

Number of Home Test Kits Ordered by Participants. Secondary · 4 months

The research team will measure HIV testing by counting the number of home test kits ordered by participants and receiving HIV test results from TBD Health. TBD Health partnered with the research team on at-home testing, laboratory work, and linking participants to care. Only participants in the treatment arm had access to at-home HIV testing; control participants did not.

Group	Value	95% CI
In-the-kNOW Mobile App.	3

Number of Participants Indicating Intention to Start PrEP Secondary · 4 months

Participants were asked about their intention to initiate PrEP during the 4-month study period using a post-test survey. Intention was assessed through a series of statements rated on a 5-point Likert scale (from 'definitely not' to 'definitely'

Do you plan on using PrEP to reduce your risk of getting HIV in the next 3 months?

Group	Value	95% CI
In-the-kNOW Mobile App.	8
Control Condition.	12
In-the-kNOW Mobile App.	11
Control Condition.	9
In-the-kNOW Mobile App.	5
Control Condition.	5
In-the-kNOW Mobile App.	2
Control Condition.	1

Do you plan on using PrEP to reduce your risk of getting HIV in the next 12 months?

Group	Value	95% CI
In-the-kNOW Mobile App.	5
Control Condition.	9
In-the-kNOW Mobile App.	14
Control Condition.	10
In-the-kNOW Mobile App.	5
Control Condition.	6
In-the-kNOW Mobile App.	1
Control Condition.	1

Do you plan to talk with your health provider about PrEP?

Group	Value	95% CI
In-the-kNOW Mobile App.	5
Control Condition.	5
In-the-kNOW Mobile App.	11
Control Condition.	13
In-the-kNOW Mobile App.	5
Control Condition.	5
In-the-kNOW Mobile App.	4
Control Condition.	4

Number of Participants Who Agreed With Statements About PrEP Initiation Secondary · 4 months

Participants were asked to select the statement that best reflected their attitude toward initiating PrEP from a predefined list of options.

I am ready to start taking PrEP for HIV prevention as soon as possible

Group	Value	95% CI
In-the-kNOW Mobile App.	1
Control Condition.	2

I have no intention of using PrEP for HIV prevention

Group	Value	95% CI
In-the-kNOW Mobile App.	19
Control Condition.	18

I am considering taking PrEP for HIV prevention, but I'm not ready to take action

Group	Value	95% CI
In-the-kNOW Mobile App.	6
Control Condition.	8

Missing

Group	Value	95% CI
In-the-kNOW Mobile App.	2
Control Condition.	0

Number of Participant's Who Initiated PrEP Treatment Secondary · 4 months

The research team asked participants about their PrEP initiation. Response options were yes/no if participants had started PrEP by the end of the study period.

Group	Value	95% CI
In-the-kNOW Mobile App.	0
Control Condition.	0

Number of Enrolled Participants by Recruiting Source Secondary · 4 months

Enrolled participants were asked how they heard about the study, allowing researchers to determine which method yielded the largest number of enrolled individuals.

Group	Value	95% CI
In-the-kNOW Mobile App.	21
Control Condition.	16
In-the-kNOW Mobile App.	0
Control Condition.	0
In-the-kNOW Mobile App.	1
Control Condition.	0
In-the-kNOW Mobile App.	0
Control Condition.	0

Number of Participants Reporting Smartphone Ownership Secondary · 4 months

Participants who owned/used their smartphones for the intervention.

Group	Value	95% CI
In-the-kNOW Mobile App.	28
Control Condition.	28

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.