Helping Men Have Healthy Babies

NCT ID: NCT03818984

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-06
• Study Completion Date: 2017-10-25

Brief Summary

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.

Detailed 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.

Conditions

HIV/AIDS; HIV Prevention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Safer Conception Intervention

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.

Group Type: EXPERIMENTAL

Safer Conception for Men with At Risk Partners

Intervention Type: BEHAVIORAL

CBT based safer conception counseling with longitudinal follow-up and booster sessions. The primary outcome will be HIV RNA suppression at 6 months. Secondary outcomes include early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.

Interventions

Safer Conception for Men with At Risk Partners

CBT based safer conception counseling with longitudinal follow-up and booster sessions. The primary outcome will be HIV RNA suppression at 6 months. Secondary outcomes include early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lynn T Matthews

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Matthews LT, Psaros C, Mathenjwa M, Mosery N, Greener LR, Khidir H, Hovey JR, Pratt MC, Harrison A, Bennett K, Bangsberg DR, Smit JA, Safren SA. Demonstration and Acceptability of a Safer Conception Intervention for Men With HIV in South Africa: Pilot Cohort Study. JMIR Form Res. 2022 May 4;6(5):e34262. doi: 10.2196/34262.

Reference Type: DERIVED

PMID: 35507406 (View on PubMed)

Other Identifiers

2013P002693

Identifier Type: -

Identifier Source: org_study_id