Getting to Zero: Safer Conception Programming Among HIV Sero-different Couples in Uganda (G2Z)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03895619|
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Other: Safer conception strategies||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Proof of Concept Research|
|Masking:||None (Open Label)|
|Official Title:||Getting to Zero: Safer Conception Programming to Eliminate Sexual and Perinatal HIV Transmission Among HIV Sero-different Couples in Uganda|
|Actual Study Start Date :||November 26, 2018|
|Estimated Primary Completion Date :||November 26, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Men living with HIV
Uptake of safer conception strategies among men living with HIV and/or their female partners
Other: Safer conception strategies
Individuals and couples adopt safer conception strategies including HIV-serostatus disclosure to partner, ART uptake and adherence and HIV-RNA suppression, STI testing and treatment, timing condomless sex to peak fertility, partner ARV use (ART if living with HIV, PrEP if HIV negative), and contraception until ready to conceive.
- Number of HIV infected men and their female partners attending Safer Conception Counselling Sessions and choosing a safer conception strategy that meets their needs [ Time Frame: 1.5 year ]We will document the number of participants who return to their clinic with their female pregnancy partner to attend Safer Conception Counselling. We will also document the type of strategy chosen.
- Types of factors contributing to uptake of safer conception strategies among men living with HIV [ Time Frame: 1.5 year ]The reasons why men chose to use safer conception strategies will be better understood using unadjusted and adjusted logistic regression models (with 95% confidence intervals)
- Number of men living with HIV retained in care who are part of the safer conception intervention. [ Time Frame: 1.5 year ]Will use Kaplan-Meier methods to measure time to index loss from care
- HIV transmission incidence among HIV-affected individuals and couples where the male partner is living with HIV and engaged in the safer conception intervention. [ Time Frame: 1.5 year ]Will use Kaplan-Meier methods to measure partner HIV-seroconversion.
- Periconception HIV transmission incidence among HIV-affected individuals and couples. [ Time Frame: 1.5 year ]Cumulative incidence of pregnancy will be calculated as the total number of pregnancies over the follow-up period by person-years of follow-up.
- HIV incidence among female partners of men living with HIV engaged in the safer conception intervention. [ Time Frame: 1.5 year ]Will analyze interview data using content analysis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895619
|Contact: Angela Kaida, PhDemail@example.com|
|Immune Suppression Syndrome (ISS) Clinic at the Mbarara Regional Referral Hospital (MRRH)||Recruiting|
|Contact: Mwebesa Bosco Bwana, MBChB 256 772 308895 firstname.lastname@example.org|