Helping Men Have Healthy Babies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safer Conception for HIV-infected Men Choosing to Conceive With At-risk Partners: Sinikithemba Kwabesilisa (Helping Men Have Healthy Babies)

Conditions
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HIV Prevention, HIV/AIDS

Intervention / Treatment
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* Behavioral: Safer Conception for Men with At Risk Partners


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Men will be offered 3 safer conception counseling sessions plus 2 booster sessions
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safer Conception Intervention<br>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. | Behavioral: Safer Conception for Men with At Risk Partners<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV RNA Suppression | Proportion of men achieving HIV-RNA suppression | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of ART | The proportion of men who initiate or continue ART | 12 weeks | 
| Uptake of HIV-serostatus disclosure | The proportion of men who report disclosure of HIV serostatus to pregnancy partner | 12 weeks | 
| Use of timing condomless sex to peak fertility | Through SMS surveys to assess weekly sexual behavior the study will evaluate the proportion of men who attempt to limit condomless sex to peak fertility | 12 weeks |