- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05092997
Kingasa Pilot Study
Interventions for Improved Post-partum ART Continuation and HIV Testing of Male Partners of Women in PMTCT B+ in Uganda (Kingasa Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the Kingasa study, the investigators will use a factorial design in order to evaluate both an intervention to increase male partner HIV testing and an intervention for pregnant and postpartum women living with HIV to provide real-time HIV VL load and ART adherence counseling. Specifically, the investigators will evaluate a) whether invitations to wellness visits increase the proportion of male partners who test for HIV and b) whether POC HIV VL tests increase viral suppression among pregnant and postpartum women living with HIV. The research team will also assess the impact of providing male counselor phone call follow-up to men in the wellness visit arm to encourage linkage to HIV care and prevention after HIV testing. Women will be randomized 1:1:1:1 to receive a) standard of care interventions with an invitation letter for male partners for fast-track visit for HIV testing and laboratory HIV testing for women at enrollment and every 6 months until 12 months postpartum, b) invitation letter for male partners for fast track visit for HIV testing and POC VL tests for women at enrollment and every 6 months until 12 months postpartum; c) invitation letter to male partners for wellness visits and laboratory-based HIV VL testing for women at enrollment and every 6 months until 12 months postpartum; and d) invitation letter to male partners for wellness visits and POC viral load testing for women at enrollment and every 6 months until 12 months post-partum. Women who are randomized to receive POC VL will receive same day ART adherence counseling and those randomized to receive lab based VL will receive VL results at their next visit with ART adherence counseling based on their VL results.
Women in both arms will receive counseling to minimize social harms associated with status disclosure and HIV testing, and additional counseling and referral to social support services when social harms occur. Based on the current Ugandan MOH guidelines to offer HIVST to both HIV-positive and HIV-negative pregnant women in ANC clinics, women in both arms will be provided an HIVST to give to their partner if they choose. They will be trained in the use and interpretation of the HIVST and be given information about HIV testing and prevention and care services, which she will give to her partner.
This study has been designed to address the gap in male partner engagement by using innovative methods to link men to HIV testing, prevention and care, and thus PMTCT outcomes for women.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kampala, Uganda
- Infectious Disease Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for women:
- Age ≥18 or 14-17 years if an emancipated minor (pregnant or have a child)
- Currently pregnant
- Not currently enrolled in an HIV treatment study
- Male partner not known to be HIV-positive or has not tested in the past 3 months
- Able and willing to provide written informed consent
- Able and willing to provide adequate locator information for study retention purposes
- Screening negative for any indication of intimate partner violence or social harm
Inclusion Criteria for men:
- female partner enrolled in Kingasa pilot study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Female SOC/Male SOC arm
Women will be provided the standard of care invitation letter for male partners for fast-track visit for HIV testing and laboratory HIV testing at enrollment and every 6 months until 6 months postpartum,
|
|
Active Comparator: Female intervention/Male SOC arm
Women will be provided the standard of care invitation letter for male partners for fast-track visit for HIV testing and POC VL tests for women at enrollment, delivery, and 6 months post-partum;
|
POC viral load testing- women randomized to have POC VL at enrollment, delivery and 6 months post-partum, will have a finger prick to obtain whole blood for the Cepheid Xpert HIV-1 RNA cartridge on the Xpert IV machine with results in 90 minutes.
Women who are randomized to POC VL who have VL >200 c/ml will receive additional adherence counseling, following the STREAM protocol, [26] to address the challenges that they are having with ART use.
At the delivery visit, infants of women in the POC VL arm will also have viral load testing done.
|
Active Comparator: Female SOC/Male intervention arm
Women will be provided an invitation letter for male partners for wellness visits and laboratory-based HIV VL testing for women at enrollment, delivery, and 6 months post-partum;
|
Wellness visits for men- additional prevention services for men randomized to the intervention arm, including dual syphilis and HIV testing, blood pressure, visual acuity screening, and COVID-19 screening as part of wellness
|
Active Comparator: Female intervention/male intervention arm
Women will be provided an invitation letter for male partners invitation letter for male partners for wellness visits and POC viral load testing for women at enrollment, delivery, and 6 months post-partum.
|
POC viral load testing- women randomized to have POC VL at enrollment, delivery and 6 months post-partum, will have a finger prick to obtain whole blood for the Cepheid Xpert HIV-1 RNA cartridge on the Xpert IV machine with results in 90 minutes.
Women who are randomized to POC VL who have VL >200 c/ml will receive additional adherence counseling, following the STREAM protocol, [26] to address the challenges that they are having with ART use.
At the delivery visit, infants of women in the POC VL arm will also have viral load testing done.
Wellness visits for men- additional prevention services for men randomized to the intervention arm, including dual syphilis and HIV testing, blood pressure, visual acuity screening, and COVID-19 screening as part of wellness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Male partner linkage
Time Frame: 6 months from female partner enrollment
|
To assess the proportion of HIV-negative male partners who initiate PrEP and HIV positive men who initiate ART among male partners who test for HIV and are provided male counselor phone follow up or who receive standard of care.
|
6 months from female partner enrollment
|
Male partner HIV testing
Time Frame: 6 months from female partner enrollment
|
To determine the proportion of male partners of pregnant HIV-positive women who test for HIV at the clinic, based on invitation to a wellness visit (dual syphilis and HIV rapid test, blood pressure, visual acuity screening and COVID symptom screening, and if available, PCR testing for those with symptoms) compared to the standard of care (standard of care invitation letter for HIV fast track testing at the clinic).
|
6 months from female partner enrollment
|
Viral suppression
Time Frame: 6 months post-partum
|
To compare viral suppression (defined as less than 50 copies/mL) at 6 months post-partum among women in the intervention arm (receiving POC viral load testing and same-day ART adherence support) to women in the control arm (receiving stand of care lab-based HIV VL testing).
|
6 months post-partum
|
Acceptability evaluation
Time Frame: One time point at 3 months post-partum for women, and one time point at 3 months post enrollment for men
|
To evaluate acceptability and preferences for HIV testing and other health services among 15 pregnant women and 15 male partners using qualitative in-depth interviews.
|
One time point at 3 months post-partum for women, and one time point at 3 months post enrollment for men
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00009286
- R01MH113434 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PrEP
-
The University of Texas Health Science Center,...Merck Sharp & Dohme LLCCompletedPrEP Uptake Perspectives | PrEP Uptake Experiences | PrEP Adherence Perspectives | PrEP Adherence ExperiencesUnited States
-
University of ChicagoNorthwestern University; Ann & Robert H Lurie Children's Hospital of Chicago; Howard Brown Health Center and other collaboratorsRecruiting
-
Brown UniversityCompletedAdherence, Medication | Stimulant Abuse | PrEP UptakeUnited States
-
Children's Mercy Hospital Kansas CityUniversity of North CarolinaWithdrawn
-
Sebela Pharmaceuticals Development LLCCompletedColon Prep for ColonoscopyUnited States
-
Georgetown UniversityJohns Hopkins Bloomberg School of Public Health; United States Agency for International... and other collaboratorsRecruitingOral Pre-exposure Prophylaxis (PrEP) | Long-acting Injectable Cabotegravir for PrEPMalawi
-
Yale UniversityGilead SciencesNot yet recruitingHIV Prevention | PrEP Uptake | PrEP AwarenessUnited States
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health...Completed
-
University of Colorado, DenverNational Institute of Allergy and Infectious Diseases (NIAID); San Francisco...CompletedPrEP Adherence MonitoringUnited States
-
Boston Medical CenterGilead SciencesCompletedPrEP for Conception PurposesUnited States
Clinical Trials on POC viral load testing
-
University of WashingtonNational Institute of Mental Health (NIMH)Enrolling by invitationPrEP | HIV | PMTCT | Linkage to Care | ART AdherenceUganda
-
University of WashingtonNational Institute of Allergy and Infectious Diseases (NIAID)CompletedChronic HIV InfectionSouth Africa
-
University of Alabama at BirminghamUniversity of Colorado, Denver; National Institute of Mental Health (NIMH); University... and other collaboratorsCompletedChronic HIV InfectionKenya
-
Clinton Health Access Initiative Inc.Ministry of Health and Child Welfare, ZimbabweCompletedHIV InfectionsZimbabwe
-
Walter Reed Army Institute of Research (WRAIR)Recruiting
-
Deutsche Luft und RaumfahrtUnknownHIV Infections | Papillomavirus Infections | Anal Intraepithelial NeoplasiaGermany
-
Walter Reed Army Institute of Research (WRAIR)US Military HIV Research Program; Kenya Medical Research InstituteCompletedAcquired Immunodeficiency Syndrome | HIV Infection | RNA Virus Infections | Virus DiseasesKenya
-
Nantes University HospitalMinistry of Health, FranceCompletedBlood Coagulation Disorders | Blood Transfusion | C.Surgical Procedure; Cardiac | Bypass, Cardiopulmonary | HemostaticFrance
-
University of NebraskaWithdrawnCMV Viral Loads in Seropositive Renal Transplant RecipientsUnited States
-
Wroclaw Medical UniversityUnknownInfluenza | Vaccination | Attitude of Health PersonnelPoland