HIV
Conditions
Keywords
couple HIV testing and counseling, disclosure, discordant, HIV, Malawi
Brief 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. 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).
Interventions
BEHAVIORALcontract referral
A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
BEHAVIORALpatient referral
A patient agrees to recruit their partner using the invitation.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* Enrolled/enrolling in the PROMISE study * Initially Presenting with a male sex partner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Who Came With Their Partners and Received Couple Counseling and Testing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Female First Option B+ Follow-up Visit | three months | 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. |
| Male Linkage to Care | one month from male presentation to the clinic | 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. |
Countries
Malawi
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Referral Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
patient referral: A patient agrees to recruit their partner using the invitation. | 100 |
| Contract Referral Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
patient referral: A patient agrees to recruit their partner using the invitation. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Patient Referral | Contract Referral | Total |
|---|---|---|---|
| Age, Continuous | 26.5 years STANDARD_DEVIATION 0.49 | 26.6 years STANDARD_DEVIATION 0.5 | 26.6 years STANDARD_DEVIATION 0.35 |
| Sex: Female, Male Female | 100 Participants | 100 Participants | 200 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 3 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
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.
Time frame: three months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Referral | Number of Women Who Came With Their Partners and Received Couple Counseling and Testing | 52 Female participants receiving CHTC |
| Contract Referral | Number of Women Who Came With Their Partners and Received Couple Counseling and Testing | 70 Female participants receiving CHTC |
Secondary
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.
Time frame: three months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Referral | Female First Option B+ Follow-up Visit | 83 participants |
| Contract Referral | Female First Option B+ Follow-up Visit | 91 participants |
Secondary
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.
Time frame: one month from male presentation to the clinic
Population: These are only the HIV-infected men who participated in the study who were HIV-infected and not already engaged in care. That is why it is only a subset of the larger population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Referral | Male Linkage to Care | 5 partners linked to care |
| Contract Referral | Male Linkage to Care | 15 partners linked to care |