Helping Men Have Healthy Babies

Mass General Brigham

Status: Completed

Conditions: HIV Prevention; HIV/AIDS

Treatments: Behavioral: Safer Conception for Men with At Risk Partners

Study type: Interventional

Funder types: Other

Identifiers

NCT03818984

2013P002693

Details and patient eligibility

About

Many men living with HIV (MLWH) want to have children. HIV-RNA suppression can minimize sexual HIV transmission risks while allowing for conception. The study will evaluate a safer conception intervention that leverages men's motivations to have healthy babies in order to promote serostatus disclosure and early ART initiation. The intervention is based on the investigators' Safer Conception Conceptual Framework, which considers individual, dyadic, and structural factors that affect periconception risk behavior.

Full description

The study will evaluate and test a safer conception intervention that leverages men's motivations to have healthy babies in order to promote serostatus disclosure and early ART initiation. The intervention is based on a Safer Conception Conceptual Framework, which considers individual, dyadic, and structural factors that affect periconception risk behavior.

The researchers will conduct an open pilot to refine the intervention. The study will enroll men who want to have children with uninfected or unknown status female partners. Men will participate in three study sessions offering motivational interviewing and problem solving to help men develop a plan to have a healthy baby. The counseling will explore safer conception options including safe disclosure, delaying conception attempts until on ART with viral suppression, STI testing and treatment, timing condomless sex to peak fertility. The primary outcome is HIV RNA suppression at 12 weeks. Secondary outcomes include acceptability, feasibility, early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.

Enrollment: 28 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Identifies as male
• Not on ART, or initiated ART within the past 3 months
• HIV-positive and status known for at least 1 (one) month,
• in care/patient at iThembalabantu clinic
• want to have a child in the next year,
• with a stable sexual pregnancy partner for at least 6 months,
• their pregnancy partner should be HIV-uninfected or HIV-status unknown,
• their pregnancy partner should not be known to be currently pregnant,
• have their own/ a mobile phone
• be fluent in either English or isiZulu and,
• able to participate in informed consent process
• not sterilized or known to be infertile

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Safer Conception Intervention

Experimental group

Description:

Men will participate in 3 counseling sessions with a lay counselor. In the first session, the counselor will share information on the various safer conception strategies and help the participant think about developing a healthy plan. In the following 2 sessions, the counselor and the participant will work together to develop a healthy baby plan using motivational interviewing and problem solving. In the 2 booster sessions, the counselor and the participant will check in to evaluate the success of the plan and make changes as necessary.

Treatment:

Behavioral: Safer Conception for Men with At Risk Partners