HIVNCT02139176
Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program
A study testing contract referral and patient referral in people with HIV, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors than women. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- contract referral and patient referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMalawi
- Study dates
- Mar 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 18 years old or 16-17 years old and married
- Pregnant
- Received a positive HIV-test within the last day
- Will be in Lilongwe for the next month
- Able and willing to give locator information for >1 male partner in the Bwaila District Hospital catchment area (either a mobile number, a physical address, or both)
Who cannot join
- Enrolled/enrolling in the PROMISE study
- Initially Presenting with a male sex partner
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Bwaila District Hospital Antenatal Unit
Lilongwe, Central District
About this study
In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors than women. They are less likely to be tested for HIV, initiate combination antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage in the care of their female sex partners, even though couple care-seeking is associated with marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program for providing immediate, lifelong combination antiretroviral therapy (cART) to all HIV-infected pregnant women at the time of diagnosis, is an important entry-point for involving male partners in care.
This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male partner involvement within the Option B+ program. In both arms (patient referral and contract referral) women will be encouraged to invite their male partners to accompany them to the clinic for couple HIV counseling and testing. In the contract referral arm, if the couple does not present within one week, the male partner will receive a home visit encouraging them to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men. Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's HIV program.
Read more
Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+ context. We will assess acceptability of eligible females to participate in this pilot RCT and reasons for non-participation.
Objective 2: Assess whether study arm (patient referral versus contract referral) is associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of male partner recruitment. This study will contain two arms: patient referral and contract referral for uptake of cHTC (primary outcome).
- Conditions
- HIV
- Being tested
- contract referral, patient referral
- Keywords
- couple HIV testing and counseling, disclosure, discordant, HIV, Malawi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contract referralBehavioural
Also called partner notification, contract partner notification, invitation plus tracing
A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
patient referralBehavioural
Also called passive referral, patient notification, invitation only
A patient agrees to recruit their partner using the invitation.
| Study group | Role | What they receive |
|---|---|---|
| Patient referral | Active comparator | Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information Receives: Behavioral: patient referral |
| contract referral | Experimental | Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. Receives: Behavioral: contract referral; Behavioral: patient referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Women Who Came With Their Partners and Received Couple Counseling and Testing
Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.
Measured: three months
Secondary outcomes (2)
Female First Option B+ Follow-up Visit
It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records). The number retained will be compared.
Measured: three months
Male Linkage to Care
It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner. This will be assessed from abstraction of routine clinic records at Martin Preuss Center.
Measured: one month from male presentation to the clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nora E Rosenberg, PhD, Principal investigator, University of North Carolina, Chapel HillMina Hosseinipour, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139176
- Sponsor's protocol ID
- 13-3707
- Status last verified
- Sep 2016
- First submitted
- 13 May 2014
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng'ambi W, Miller WC, Hoffman I, Hosseinipour M. Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial. Lancet HIV. 2015 Nov;2(11):e483-91. doi: 10.1016/S2352-3018(15)00182-4. Epub 2015 Oct 22.
PubMed 26520928
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program
- ClinicalTrials.gov ID
- NCT02139176
- Acronym / sponsor ID
- 13-3707
- Conditions
- HIV
- Keywords
- couple HIV testing and counseling, disclosure, discordant, HIV, Malawi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors than women. They are less likely to be tested for HIV, initiate combination antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage in the care of their female sex partners, even though couple care-seeking is associated with marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program for providing immediate, lifelong combination antiretroviral therapy (cART) to all HIV-infected pregnant women at the time of diagnosis, is an important entry-point for involving male partners in care.
This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male partner involvement within the Option B+ program. In both arms (patient referral and contract referral) women will be encouraged to invite their male partners to accompany them to the clinic for couple HIV counseling and testing. In the contract referral arm, if the couple does not present within one week, the male partner will receive a home visit encouraging them to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men. Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's HIV program.
Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+ context. We will assess acceptability of eligible females to participate in this pilot RCT and reasons for non-participation.
Objective 2: Assess whether study arm (patient referral versus contract referral) is associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of male partner recruitment. This study will contain two arms: patient referral and contract referral for uptake of cHTC (primary outcome).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient referral | Active comparator | Behavioral: patient referralWomen are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information |
| contract referral | Experimental | Behavioral: contract referral, Behavioral: patient referralSame as control. However, if the male partner does not present, a community worker will trace the partner in the community. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old or 16-17 years old and married
Key exclusion criteria (2 listed)
- Enrolled/enrolling in the PROMISE study
- Initially Presenting with a male sex partner
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 |
|---|---|---|
| contract referralAlso: partner notification, contract partner notification, invitation plus tracingA female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community. | Behavioural | contract referral |
| patient referralAlso: passive referral, patient notification, invitation onlyA patient agrees to recruit their partner using the invitation. | Behavioural | Patient referral, contract referral |
Primary outcome
Number of Women Who Came With Their Partners and Received Couple Counseling and Testing
Time frame: three months
Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.
2 secondary outcomes
Female First Option B+ Follow-up Visit
Time frame: three months
Male Linkage to Care
Time frame: one month from male presentation to the clinic
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26520928Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng'ambi W, Miller WC, Hoffman I, Hosseinipour M. Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial. Lancet HIV. 2015 Nov;2(11):e483-91. doi: 10.1016/S2352-3018(15)00182-4. Epub 2015 Oct 22.
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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.
Nora E Rosenberg, PhD principal investigator
University of North Carolina, Chapel Hill
Mina Hosseinipour, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contract referral and patient referral in people with HIV, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
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 5 inclusion and 2 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 7 Aug 2017. 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 Malawi. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Women Who Came With Their Partners and Received Couple Counseling and Testing (time frame: three months). 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 NCT02139176, 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 7 Aug 2017.