HIV Infections Clinical Trial
— G2ZOfficial title:
Getting to Zero: Safer Conception Programming to Eliminate Sexual and Perinatal HIV Transmission Among HIV Sero-different Couples in Uganda
Verified date | April 2020 |
Source | Simon Fraser University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Despite effective strategies to reduce periconception HIV transmission, there are few services to support people living with or affected by HIV to use these methods. In particular, there is a lack of safer conception services focused on engaging men living with HIV. Given known gender inequities in childbearing decision-making and HIV risk, it is critical that safer conception services deliver programming that engages men living with HIV and their HIV sero-different partners. The Healthy Families program, based at the ISS Clinic at Mbarara Regional Referral Hospital, offers client-centered safer conception care to help HIV-affected individuals and couples meet reproductive goals. This care supports clients to leverage personal motivations and partner and social supports to overcome structural barriers and use Antiretroviral Therapy (ART), adopt other HIV-prevention strategies, and remain in care. This pilot study (the 'Getting to Zero' study) will assess uptake and experiences of safer conception care among 50 men living with HIV and their HIV sero-different partners. Investigators will also assess men's retention in HIV care and HIV transmission risk to partners and infants. This is a one-year mixed-methods prospective pilot research study, which will use electronic chart review data, longitudinal survey data (from the male index and female partner participant), and qualitative data from in-depth semi-structured interviews to meet study objectives. By demonstrating safer conception uptake and impact on HIV transmission risks to partners and infants, investigators aim to inform HIV and reproductive health policy in Uganda and globally.
Status | Completed |
Enrollment | 47 |
Est. completion date | October 31, 2019 |
Est. primary completion date | September 26, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: For enrollment in the Getting to Zero study, eligibility criteria for the index participant include the following: 1. Identify as male 2. HIV-positive 3. Report personal or partner desire to have a child in the next year 4. Identified pregnancy partner is reported to be HIV-negative or he doesn't know her HIV serostatus. 5. Aged 18 years or older. 6. Be naïve to the Healthy Families program. 7. Live within 60km of the ISS clinic and not planning to relocate to an area incompatible with an ability to attend the clinic over a 1 year follow-up period. 8. Able and willing to participate in the informed consent process. Men living with HIV enrolled in the Getting to Zero study (index participants) will be asked for their consent to contact their partners to determine eligibility, interest, and willingness to participate in the Getting to Zero study. Partner participants must meet the following inclusion criteria: 1. Identify as a partner of an enrolled male Getting to Zero participant 2. Aged 18 years or older 3. Able and willing to participate in the informed consent process. These participants will be referred to as the "partner". If the female partner is identified as HIV-positive after the male index participant enrolls in the Getting to Zero study, both partners remain eligible to participate. Exclusion Criteria for Index Participant: 1. Identify as female 2. HIV-negative 3. Does not report personal or partner desire to have a child in the next year 4. Identified pregnancy partner is reported to be HIV-positive 5. Under age 18 years. 6. Be a patient of the Healthy Families program. 7. Live greater than 60km of the ISS clinic and planning to relocate to an area incompatible with attending the clinic over a 1 year follow-up period. 8. Unable and unwilling to participate in the informed consent process. |
Country | Name | City | State |
---|---|---|---|
Uganda | Immune Suppression Syndrome (ISS) Clinic at the Mbarara Regional Referral Hospital (MRRH) | Mbarara |
Lead Sponsor | Collaborator |
---|---|
Simon Fraser University | Massachusetts General Hospital, Mbarara University of Science and Technology |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of HIV infected men and their female partners attending Safer Conception Counselling Sessions and choosing a safer conception strategy that meets their needs | 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. | 1.5 year | |
Secondary | Types of factors contributing to uptake of safer conception strategies among men living with HIV | 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) | 1.5 year | |
Secondary | Number of men living with HIV retained in care who are part of the safer conception intervention. | Will use Kaplan-Meier methods to measure time to index loss from care | 1.5 year | |
Secondary | HIV transmission incidence among HIV-affected individuals and couples where the male partner is living with HIV and engaged in the safer conception intervention. | Will use Kaplan-Meier methods to measure partner HIV-seroconversion. | 1.5 year | |
Secondary | Periconception HIV transmission incidence among HIV-affected individuals and couples. | Cumulative incidence of pregnancy will be calculated as the total number of pregnancies over the follow-up period by person-years of follow-up. | 1.5 year | |
Secondary | HIV incidence among female partners of men living with HIV engaged in the safer conception intervention. | Will analyze interview data using content analysis. | 1.5 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT06072443 -
AURORA Study-A Transformative Approach to Support PrEP Medication Persistence
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|