Who is sponsoring NCT04758390?

NCT04758390 is sponsored by University of Illinois at Chicago.

What drugs are being tested in NCT04758390?

Interventions in NCT04758390: IMARA (intervention group), Health promotion control group.

What condition does NCT04758390 study?

NCT04758390 studies Sexually Transmitted Infections, HIV Infections.

Is NCT04758390 still recruiting?

NCT04758390 is currently completed. Last updated 20 January 2025.

Last reviewed 2025-01-20 · How we verify

NCT04758390: IMARA-SA

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

A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women

Completed NA Last updated 20 January 2025

What this trial tests

NA trial testing IMARA (intervention group) in Sexually Transmitted Infections in 1,290 participants. Completed in 4 October 2024.

Timeline

2 October 2021

Primary endpoint
7 April 2024

4 October 2024

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,290
Start date	2 October 2021
Primary completion	7 April 2024
Estimated completion	4 October 2024
Sites	1 location across South Africa

Drugs / interventions tested

IMARA (intervention group)
Health promotion control group

Conditions studied

Sexually Transmitted Infections — all drugs for Sexually Transmitted Infections →
HIV Infections — all drugs for HIV Infections →

Sponsor

University of Illinois at Chicago

Who can join

Adults 15 to 19, female only, with Sexually Transmitted Infections or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To achieve an AIDS-free generation, there is a critical need for programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa. Informed, Motivated, Aware, and Responsible Adolescents and Adults (IMARA) is an evidence-based HIV-prevention intervention for adolescent girls and young women (AGYW) and their female caregivers, which has been adapted for a South African audience. The study will test whether AGYW receiving IMARA will have fewer sexually-transmitted infections (STI) and greater acceptance of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at 6-month follow-up compared to AGYW assigned to the health-promotion control intervention.

Publications & conference data

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

Mental health outcomes of a pilot 2-arm randomized controlled trial of a HIV-prevention program for South African adolescent girls and young women and their female caregivers.
Donenberg G, Merrill KG, Atujuna M, Emerson E, et al · · 2021 · cited 11× · PMID 34847908 · DOI 10.1186/s12889-021-12010-1
Integrating Adolescent Mental Health into HIV Prevention and Treatment Programs: Can Implementation Science Pave the Path Forward?
Boshe J, Brtek V, Beima-Sofie K, Braitstein P, et al · · 2023 · cited 6× · PMID 36322219 · DOI 10.1007/s10461-022-03876-2
An individually randomized controlled trial of a mother-daughter HIV/STI prevention program for adolescent girls and young women in South Africa: IMARA-SA study protocol.
Donenberg GR, Atujuna M, Merrill KG, Emerson E, et al · · 2021 · cited 6× · PMID 34544403 · DOI 10.1186/s12889-021-11727-3

Verify or expand the search:

Other recruiting trials for Sexually Transmitted Infections

Currently open trials in the same condition.

NCT06043596 — Evaluation of the SafeSpace App Intervention · NA · recruiting

Other University of Illinois at Chicago trials

Trials by the same sponsor.

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NCT07504120 — The Effect of Remotely Delivered Pilates on Physical , and Psychological Outcomes in Individuals With Multiple Sclerosis · NA · not yet recruiting
NCT07160582 — Cognitive-Motor Training for AD/ADRD Prevention · NA · not yet recruiting
NCT07498348 — Apple Watch Evaluation of Endodontics Occupational Stress · not yet recruiting

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 NCT04758390 (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 Illinois at Chicago
Last refreshed: 20 January 2025

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/NCT04758390.

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