Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study)

NCT05388084 | Completed DMC

• 3 other identifiers: STUDY000149631R01MH113434-011K01MH115789-01A1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

It is critical to evaluate strategies that leverage women's engagement in antenatal care to increase male partner testing while alleviating the burden on pregnant women to encourage their male partners to HIV test. A peer-delivered status-neutral approach to male partners of pregnant women may be an innovative strategy to overcome barriers to men's reluctance to test for HIV and initiate HIV prevention or treatment services. For pregnant women living with HIV, partner testing and disclosure could facilitate women's continuation of ART post-partum, and for HIV-negative women at risk of HIV acquisition, this could facilitate women's initiation of PrEP during pregnancy. Thus, multiple public health goals could be achieved through increasing the proportion of men who know their HIV status.

Conditions

Engagement, Patient; Male Peer Recruitment; HIV Testing; Linkage to Care

Keywords

Engagement, Patient; Male peer recruitment; HIV testing; PrEP; ART

Outcome Measures

Primary Outcomes (3)

• Male partner HIV testing

  The outcome for Aim 1 is the proportion of men who test for HIV in the intervention arm compared to those who test in the control arm. Endpoint: Site verified HIV test in a male partner of an enrolled women within three months of the women's enrollment

  3 months from female partner enrollment

• Linkage to PrEP

  The outcome for Aim 2 is the proportion of male partners who test HIV-negative and have an indication for PrEP who initiate PrEP compared to the SOC arm.

  3 months from female partner

• Linkage to ART

  The outcome for Aim 3 is the proportion of male partners who test HIV-positive and initiate ART compared to the SOC arm.

  3 months from female partner

Study Arms (2)

Male peer led intervention

ACTIVE COMPARATOR

Male partners of women randomized to the intervention arm will receive a phone call from the male peer to encourage them to test for HIV at the clinic. Male peer fathers will offer to meet men at the clinic and guide them through the process of HIV testing. Men who are not willing/able to attend the clinic for HIV testing will be offered testing in a private and confidential location in the community; the peer male counselor meet men and offer to assist them through the process of using and interpreting an oral HIVST. Men who are not interested in testing with the peer father will be offered the HIVST kit to take home. Peer fathers will obtain men's consent to participate in the study.

Behavioral: Male peer engagement

Standard of care and delayed intervention

ACTIVE COMPARATOR

Standard of care standard of care invitation letter to provide to their partner for fast-track HIV testing and male peer father phone calls after a 3 month delay.

Behavioral: SOC and delayed intervention

Interventions

Male peer engagement BEHAVIORAL

Male partners of women randomized to the intervention arm will receive a phone call from the male peer to encourage them to test for HIV at the clinic. Male peer fathers will offer to meet men at the clinic and guide them through the process of HIV testing. Men who are not willing/able to attend the clinic for HIV testing will be offered testing in a private and confidential location in the community; the peer male counselor meet men and offer to assist them through the process of using and interpreting an oral HIVST. Men who are not interested in testing with the peer father will be offered the HIVST kit to take home. Peer fathers will obtain men's consent to participate in the study.

Male peer led intervention

SOC and delayed intervention BEHAVIORAL

Females receive standard of care invitation letter to provide to their partner for fast-track HIV testing and male peer father phone calls after a 3 month delay.

Standard of care and delayed intervention

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years or if 14-17 years, qualified as emancipated minors (individuals below the age of majority who are pregnant)
• Currently pregnant
• Not currently enrolled in an HIV treatment study
• Male partner not known to be HIV-positive or has not tested in the past 3 months
• Able and willing to provide written informed consent
• Able and willing to provide adequate locator information for study retention purposes
• At low risk of intimate partner violence
• For men
• Has a female partner enrolled in the Okutuuka study
• Able and willing to provide written informed consent

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Infectious Disease Institute

Kampala, Uganda

Location

Related Publications (1)

• Naddunga F, Bulterys MA, Nakyanzi A, Donnell D, Kyomugisha J, Birungi JE, Ssendiwala P, Nsubuga R, Muwonge TR, Musinguzi J, Peacock S, Celum CL, Mujugira A, Sharma M. Impact of male peer-led outreach on uptake of HIV testing among male partners of pregnant women in Uganda: a randomized trial. J Int AIDS Soc. 2025 Apr;28(4):e26440. doi: 10.1002/jia2.26440.

  PMID: 40141016 DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Connie Celum, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Global Health

Model Details: We will recruit pregnant women to be randomized to: 1) the intervention arm (peer father phone call) or 2) the delayed intervention arm, standard of care standard of care invitation letter to provide to their partner for fast-track HIV testing and male peer father phone calls after a 3 month delay. Women in both arms will receive an HIVST kit from the ANC clinic per standard of care guidelines. In the delayed intervention arm, men who have not HIV tested after 3 months of female partner enrollment will receive the intervention of a peer father phone call.

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 24, 2022
• Study Start: May 20, 2022
• Primary Completion: May 31, 2023
• Study Completion: July 15, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)