NCT04426656 is a NA clinical trial of Phone application in HIV, sponsored by University of North Carolina, Chapel Hill.

Who is sponsoring NCT04426656?

NCT04426656 is sponsored by University of North Carolina, Chapel Hill.

What drugs are being tested in NCT04426656?

Interventions in NCT04426656: Phone application.

What condition does NCT04426656 study?

NCT04426656 studies HIV, Pre-exposure Prophylaxis.

Is NCT04426656 still recruiting?

NCT04426656 is currently completed. Last updated 2 March 2022.

Are results published for NCT04426656?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-03-02 · How we verify

NCT04426656

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China

Completed NA Results posted Last updated 2 March 2022

What this trial tests

NA trial testing Phone application in HIV in 70 participants. Completed in 2 April 2021.

Timeline

8 July 2020

Primary endpoint
2 April 2021

2 April 2021

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	70
Start date	8 July 2020
Primary completion	2 April 2021
Estimated completion	2 April 2021
Sites	1 location across China

Drugs / interventions tested

Phone application

Conditions studied

HIV — all drugs for HIV →
Pre-exposure Prophylaxis — all drugs for Pre-exposure Prophylaxis →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 99, male only, with HIV or Pre-exposure Prophylaxis. 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.

Change in Intention to Use PrEP Score Primary · Baseline and up to 12 weeks

Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.

Baseline to Week 4

Group	Value	95% CI
Part 2 Standard of Care	0.19	± 1.72
Part 2 Mini-app	0.00	± 2.32

Baseline to Week 8

Group	Value	95% CI
Part 2 Standard of Care	0.57	± 2.62
Part 2 Mini-app	-0.09	± 2.29

Baseline to Week 12

Group	Value	95% CI
Part 2 Standard of Care	1.00	± 2.59
Part 2 Mini-app	-0.40	± 2.59

Number of Participants Who Initiate PrEP by Week 8 Primary · Up to 8 weeks

Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)

Group	Value	95% CI
Part 2 Standard of Care	5
Part 2 Mini-app	8

Number of Participants at Different Change Stages to PrEP Initiation at Baseline Primary · Baseline

Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.

Group	Value	95% CI
Part 2 Standard of Care	9
Part 2 Mini-app	15
Part 2 Standard of Care	8
Part 2 Mini-app	24
Part 2 Standard of Care	4
Part 2 Mini-app	4
Part 2 Standard of Care	0
Part 2 Mini-app	0

Number of Participants at Different Change Stages to PrEP Initiation at Week 4 Primary · Week 4

Group	Value	95% CI
Part 2 Standard of Care	10
Part 2 Mini-app	15
Part 2 Standard of Care	5
Part 2 Mini-app	12
Part 2 Standard of Care	6
Part 2 Mini-app	12
Part 2 Standard of Care	0
Part 2 Mini-app	4

Number of Participants at Different Change Stages to PrEP Initiation at Week 8 Primary · Week 8

Group	Value	95% CI
Part 2 Standard of Care	8
Part 2 Mini-app	20
Part 2 Standard of Care	4
Part 2 Mini-app	7
Part 2 Standard of Care	4
Part 2 Mini-app	8
Part 2 Standard of Care	5
Part 2 Mini-app	8

Number of Participants at Different Change Stages to PrEP Initiation at Week 12 Primary · Week 12

Group	Value	95% CI
Part 2 Standard of Care	8
Part 2 Mini-app	17
Part 2 Standard of Care	3
Part 2 Mini-app	11
Part 2 Standard of Care	5
Part 2 Mini-app	7
Part 2 Standard of Care	5
Part 2 Mini-app	8

Change in PrEP Knowledge Score at Week 4, 8 and 12 Secondary · Baseline and up to 12 weeks

Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.

Baseline to Week 4

Group	Value	95% CI
Part 2 Standard of Care	0.33	± 0.72
Part 2 Mini-app	0.13	± 0.79

Baseline to Week 8

Group	Value	95% CI
Part 2 Standard of Care	0.33	± 0.66
Part 2 Mini-app	0.16	± 0.78

Baseline to Week 12

Group	Value	95% CI
Part 2 Standard of Care	0.38	± 0.50
Part 2 Mini-app	0.19	± 0.82

Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP Secondary · Up to 12 weeks

Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.

Baseline

Group	Value	95% CI
Part 2 Standard of Care	0
Part 2 Mini-app	6
Part 2 Standard of Care	0
Part 2 Mini-app	0
Part 2 Standard of Care	0
Part 2 Mini-app	4
Part 2 Standard of Care	1
Part 2 Mini-app	6

Week 4

Group	Value	95% CI
Part 2 Standard of Care	0
Part 2 Mini-app	4
Part 2 Standard of Care	0
Part 2 Mini-app	0
Part 2 Standard of Care	0
Part 2 Mini-app	7
Part 2 Standard of Care	5
Part 2 Mini-app	5

Week 8

Group	Value	95% CI
Part 2 Standard of Care	0
Part 2 Mini-app	5
Part 2 Standard of Care	0
Part 2 Mini-app	1
Part 2 Standard of Care	1
Part 2 Mini-app	4
Part 2 Standard of Care	4
Part 2 Mini-app	5

Week 12

Group	Value	95% CI
Part 2 Standard of Care	0
Part 2 Mini-app	3
Part 2 Standard of Care	0
Part 2 Mini-app	1
Part 2 Standard of Care	2
Part 2 Mini-app	5
Part 2 Standard of Care	8
Part 2 Mini-app	8

Change in PrEP Self-Efficacy Score Secondary · Baseline and up to 12 weeks

Self-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.

Baseline to Week 4

Group	Value	95% CI
Part 2 Standard of Care	0.05	± 0.40
Part 2 Mini-app	0.07	± 0.39

Baseline to Week 8

Group	Value	95% CI
Part 2 Standard of Care	0.08	± 0.50
Part 2 Mini-app	0.03	± 0.41

Baseline to Week 12

Group	Value	95% CI
Part 2 Standard of Care	0.10	± 0.47
Part 2 Mini-app	0.13	± 0.44

Change in PrEP Attitude Score Secondary · Baseline and up to 12 weeks

Individual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12.

Baseline to Week 4

Group	Value	95% CI
Part 2 Standard of Care	0.06	± 0.32
Part 2 Mini-app	0.07	± 0.66

Baseline to Week 8

Group	Value	95% CI
Part 2 Standard of Care	0.23	± 0.79
Part 2 Mini-app	0.01	± 0.72

Baseline to Week 12

Group	Value	95% CI
Part 2 Standard of Care	0.02	± 0.44
Part 2 Mini-app	0.02	± 0.72

Change in PrEP Stigma Score Secondary · Baseline and up to 12 weeks

Individual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12.

Baseline to Week 4

Group	Value	95% CI
Part 2 Standard of Care	0.06	± 0.32
Part 2 Mini-app	-0.02	± 0.69

Baseline to Week 8

Group	Value	95% CI
Part 2 Standard of Care	0.23	± 0.79
Part 2 Mini-app	0.09	± 0.72

Baseline to Week 12

Group	Value	95% CI
Part 2 Standard of Care	0.02	± 0.44
Part 2 Mini-app	0.03	± 0.72

Number of Participants Who Ordered At-home HIV/Syphilis Tests Secondary · 12 weeks

Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.

Group	Value	95% CI
Part 2 Mini-app	13

Sponsor's own description

This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM). UNC investigators will work in close partnership with a well-established HIV special hospital and the local MSM community to understand key barriers to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM in Guangzhou, China.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Community-engaged mHealth intervention to increase uptake of HIV pre-exposure prophylaxis (PrEP) among gay, bisexual and other men who have sex with men in China: study protocol for a pilot randomised controlled trial.
Li C, Xiong Y, Muessig KE, Tang W, et al · · 2022 · cited 15× · PMID 35537794 · DOI 10.1136/bmjopen-2021-055899
An instant messaging mobile phone application for promoting HIV pre-exposure prophylaxis uptake among Chinese gay, bisexual and other men who have sex with men: A mixed methods feasibility and piloting randomized controlled trial study.
Li C, Xiong Y, Maman S, Matthews DD, et al · · 2023 · cited 8× · PMID 37956177 · DOI 10.1371/journal.pone.0285036
A community-engaged mHealth intervention to increase uptake of HIV Pre-Exposure Prophylaxis (PrEP) among gay, bisexual and other men who have sex with men in China: Study protocol for a pilot randomized controlled trial
Li C, Xiong Y, Muessig KE, Tang W, et al · · 2020 · cited 1× · DOI 10.1101/2020.10.19.20215400

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04426656 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 2 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04426656.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04426656

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for HIV

Other University of North Carolina, Chapel Hill trials

Verify against primary sources