Engagement, PatientOkutuukaNCT05388084
Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study)
A study testing Male peer engagement and SOC and delayed intervention in people with Engagement, Patient and Male Peer Recruitment, run by University of Washington at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Engagement, Patient, Male Peer Recruitment, HIV Testing
- What is being tested?
- Male peer engagement and SOC and delayed intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUganda
- Study dates
- 20 May 2022to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -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
Show all 10Show fewer
- 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
Who cannot join
- not meeting all of the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Overall design
This is a randomized trial of pregnant women and their male partners. The overall goal is to evaluate the impact of innovative strategies to increase male partner HIV testing and engagement in HIV care and prevention through ANC services provided to pregnant women. The intervention consists of a phone call from a trained peer father to encourage male partners of pregnant women to test for HIV. Men will first be encouraged to come to the clinic for HIV testing and counseling. Those who are not willing/able to attend the clinic will be offered the option of meeting a male counselor to receive HIV testing in a convenient location in the community. The study team 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. This is being done for ethical reasons since preliminary data show phone calls from men may be effective in increasing men's HIV testing. All study outcomes will be collected by 3 months post female partner enrollment so providing the delayed intervention will not impact the study team's ability to measure the study's effectiveness. The study team will recommend that all HIV-positive participants initiate ART, and all HIV-negative participants who are eligible, initiate PrEP.
Objectives
Aim 1: To assess whether a male peer-delivered, status-neutral outreach to male partners of pregnant women increases the proportion of partners who test compared to the standard of care (invitation letters for fast-track testing and HIVST delivered by the pregnant woman).
Rationale: Innovations are needed to address the challenges associated with reaching male partners of pregnant women with HIV testing and linkage to ART or PrEP depending on their HIV serostatus.
Hypothesis: A male peer delivered, status-neutral approach to male partner engagement may overcome male partners reluctance to be tested for HIV and women's reluctance to approach their male partners about HIV testing. Approach: The investigators will randomize women 1:1 to the intervention or delayed arm and determine the proportion of male partners who test for HIV within 1 month after the female partner is randomized. The outcome will male partner testing based on male HIV testing in the two arms.
Aim 2: To determine the proportion of male partners who test HIV-negative and have an indication for PrEP who initiate PrEP and the proportion of partners who test HIV-positive who initiate ART compared to the SOC arm.
Rationale: Men who are HIV-negative are a priority for PrEP if they have a known HIV-positive partner or multiple partners, including during late pregnancy and postpartum when men are more likely to have sex with outside partners.
Hypothesis: Trained male peers will be effective in addressing men's reluctance to link to ART or PrEP and facilitating linkage to care or prevention.
Approach: Men who test for HIV through either arm will be referred for ART (if HIV-positive) or PrEP (if HIV-negative and reports multiple partners or an HIV positive partner) through the trained male peer counselor in the intervention arm or health care provider in the SOC arm. The research team will evaluate linkage to PrEP or ART among men who test for HIV, by arm.
Aim 3: To qualitatively assess acceptability of peer-delivered, status-neutral outreach to promote HIV testing among male partners of pregnant women.
Rationale: Assessment of acceptability is a key component of evaluating any novel intervention. The research team will use qualitative methods to investigate acceptability and preferences for HIV testing services among male partners of pregnant women in the cohort.
Hypothesis: A peer delivered, status-neutral approach to male partner engagement will be acceptable to recipients.
Approach: The research team will conduct individual qualitative interviews with a randomly selected subsample of 20 male partners who received peer-delivered outreach to evaluate intervention acceptability.
- Being tested
- Male peer engagement, SOC and delayed intervention
- Keywords
- Engagement, Patient, Male peer recruitment, HIV testing, PrEP, ART
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male peer engagementBehavioural
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.
SOC and delayed interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: SOC and delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 3 months from female partner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start20 May 2022
- Primary completion31 May 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Engagement, PatientStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Connie Celum, University of Washington
- Investigators
- Connie Celum, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388084
- Sponsor's protocol ID
- STUDY00014963
- Other IDs
- 1R01MH113434-01, 1K01MH115789-01A1
- Acronym
- Okutuuka
- Status last verified
- Nov 2023
- First submitted
- 16 May 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40141016
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study)
- ClinicalTrials.gov ID
- NCT05388084
- Acronym / sponsor ID
- Okutuuka / STUDY00014963
- Keywords
- Engagement, Patient, Male peer recruitment, HIV testing, PrEP, ART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 May 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overall design
This is a randomized trial of pregnant women and their male partners. The overall goal is to evaluate the impact of innovative strategies to increase male partner HIV testing and engagement in HIV care and prevention through ANC services provided to pregnant women. The intervention consists of a phone call from a trained peer father to encourage male partners of pregnant women to test for HIV. Men will first be encouraged to come to the clinic for HIV testing and counseling. Those who are not willing/able to attend the clinic will be offered the option of meeting a male counselor to receive HIV testing in a convenient location in the community. The study team 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. This is being done for ethical reasons since preliminary data show phone calls from men may be effective in increasing men's HIV testing. All study outcomes will be collected by 3 months post female partner enrollment so providing the delayed intervention will not impact the study team's ability to measure the study's effectiveness. The study team will recommend that all HIV-positive participants initiate ART, and all HIV-negative participants who are eligible, initiate PrEP.
Objectives
Aim 1: To assess whether a male peer-delivered, status-neutral outreach to male partners of pregnant women increases the proportion of partners who test compared to the standard of care (invitation letters for fast-track testing and HIVST delivered by the pregnant woman).
Rationale: Innovations are needed to address the challenges associated with reaching male partners of pregnant women with HIV testing and linkage to ART or PrEP depending on their HIV serostatus.
Hypothesis: A male peer delivered, status-neutral approach to male partner engagement may overcome male partners reluctance to be tested for HIV and women's reluctance to approach their male partners about HIV testing. Approach: The investigators will randomize women 1:1 to the intervention or delayed arm and determine the proportion of male partners who test for HIV within 1 month after the female partner is randomized. The outcome will male partner testing based on male HIV testing in the two arms.
Aim 2: To determine the proportion of male partners who test HIV-negative and have an indication for PrEP who initiate PrEP and the proportion of partners who test HIV-positive who initiate ART compared to the SOC arm.
Rationale: Men who are HIV-negative are a priority for PrEP if they have a known HIV-positive partner or multiple partners, including during late pregnancy and postpartum when men are more likely to have sex with outside partners.
Hypothesis: Trained male peers will be effective in addressing men's reluctance to link to ART or PrEP and facilitating linkage to care or prevention.
Approach: Men who test for HIV through either arm will be referred for ART (if HIV-positive) or PrEP (if HIV-negative and reports multiple partners or an HIV positive partner) through the trained male peer counselor in the intervention arm or health care provider in the SOC arm. The research team will evaluate linkage to PrEP or ART among men who test for HIV, by arm.
Aim 3: To qualitatively assess acceptability of peer-delivered, status-neutral outreach to promote HIV testing among male partners of pregnant women.
Rationale: Assessment of acceptability is a key component of evaluating any novel intervention. The research team will use qualitative methods to investigate acceptability and preferences for HIV testing services among male partners of pregnant women in the cohort.
Hypothesis: A peer delivered, status-neutral approach to male partner engagement will be acceptable to recipients.
Approach: The research team will conduct individual qualitative interviews with a randomly selected subsample of 20 male partners who received peer-delivered outreach to evaluate intervention acceptability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Male peer led intervention | Active comparator | Behavioral: Male peer engagementMale 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. |
| Standard of care and delayed intervention | Active comparator | Behavioral: SOC and delayed interventionStandard 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- -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
Key exclusion criteria (1 listed)
- not meeting all of the above inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Male peer engagementMale 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. | Behavioural | Male peer led intervention |
| SOC and delayed interventionFemales 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. | Behavioural | Standard of care and delayed intervention |
Primary outcome
Male partner HIV testing
Time frame: 3 months from female partner enrollment
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
Linkage to PrEP
Time frame: 3 months from female partner
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.
Linkage to ART
Time frame: 3 months from female partner
The outcome for Aim 3 is the proportion of male partners who test HIV-positive and initiate ART compared to the SOC arm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 40141016Naddunga 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Celum, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Male peer engagement and SOC and delayed intervention in people with Engagement, Patient and Male Peer Recruitment, run by University of Washington at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Male partner HIV testing (time frame: 3 months from female partner enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.