Clinical trial NCT03818984: Helping Men Have Healthy Babies
Official title: Safer Conception for HIV-infected Men Choosing to Conceive With At-risk Partners: Sinikithemba Kwabesilisa (Helping Men Have Healthy Babies)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
HIV Prevention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Men will be offered 3 safer conception counseling sessions plus 2 booster sessions
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: HIV RNA Suppression
timeFrame: 12 weeks
Secondary outcomes:
measure: Uptake of ART
timeFrame: 12 weeks
measure: Uptake of HIV-serostatus disclosure
timeFrame: 12 weeks
measure: Use of timing condomless sex to peak fertility
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.