Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03030768 · ClinicalTrials.gov registry record
Safer Conception Intervention for HIV-1 Serodiscordant Couples
A clinical trial of Pregnancy, High Risk and HIV Seropositivity, sponsored by University of Washington.
- Completed
- Registry status
- 74
- Enrollment target
- 2
- Study locations
NCT03030768: Completed study of Pregnancy, High Risk and HIV Seropositivity, sponsored by University of Washington.
NCT03030768 is a study of Pregnancy, High Risk and HIV Seropositivity that has completed, run by University of Washington. The registered enrollment target is 74 participants, below the 314-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03030768, a study of Pregnancy, High Risk and HIV Seropositivity, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- 74 participants
- Enrollment target
- 2
- Study locations
Study Summary
The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term heterosexual HIV-1 serodiscordant partnerships. Such couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and relinquish their childbearing desires. Based on evidence from rigorous clinical trials demonstrating the strong efficacy of individual interventions for HIV-1 prevention and formative work with HIV-1 serodiscordant couples and clinicians with expertise in HIV-1 prevention and reproductive health in the Kenyan context, this study pilots a safer conception intervention that focuses on antiretrovirals (as antiretroviral therapy \[ART\] taken by the HIV-1 infected partner and pre-exposure prophylaxis \[PrEP\] taken by the HIV-1 uninfected partner) and timed condomless sex. Additional strategies for couples include diagnosis and treatment of STIs and male circumcision. mHealth tools, including SMS and mobile applications are novel and very popular among Kenyans to ease the burden of addressing health problems. This safer conception intervention incorporates mHealth tools to improve couples' experiences tracking fertility indicators and communicating with providers about their readiness to practice safer conception. SMS surveys to collect daily information from women about their fertility signs and SMS messages are used to reinforce HIV-1 prevention, including condom use for couples during periods that do not have a high likelihood of fertility. An in-clinic mobile application is used to improve clinician-patient counseling and assessments of couple readiness to practice safer conception. To inform future engagement of mHealth tools, the investigators will prospectively evaluate clinician and patient experiences using SMS surveys and the tablet application. Couples with immediate fertility intentions will be followe
Primary Outcome
Rate of pregnancy that occur without HIV-1 transmission to the uninfected partner
Conditions Studied
Interventions
- DRUG PrEP
- BEHAVIORAL Counseling on timed condomless sex, ART and PrEP adherence
Study Locations (2)
Washington
- University of Washington, Coordinating Center - Seattle
Other
- Partners in Health, Research and Development - Thika
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2016-02 |
| Est. Completion | 2018-07 |
What the finished NCT03030768 record still lists
NCT03030768 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 314-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Pregnancy, High Risk appearing as the primary indexed condition, and to 2 interventions - of which PrEP is the first listed.
NCT03030768 reports a single indexed study location in Washington, Other.
Frequently Asked Questions
What is clinical trial NCT03030768 about?
NCT03030768 is a clinical study titled "Safer Conception Intervention for HIV-1 Serodiscordant Couples". The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term heterosexual HIV-1 serodiscordant partnerships. Such couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to co...
What is the current status of trial NCT03030768?
This trial is currently completed. The enrollment target is 74 participants. The study started on 2016-02. Estimated completion is 2018-07.
What conditions does trial NCT03030768 study?
This clinical trial studies the following conditions: Pregnancy, High Risk, HIV Seropositivity.
What interventions are being tested in trial NCT03030768?
The interventions under investigation include: PrEP (DRUG), Counseling on timed condomless sex, ART and PrEP adherence (BEHAVIORAL).
Who is sponsoring clinical trial NCT03030768?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03030768 being conducted?
This trial has 2 study locations across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy, High Risk
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03030768's enrollment target sits among peer trials
74 13th of 20 higher than 8 of 20 other Pregnancy, High Risk trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy, High Risk trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Continuous Glucose Monitor Use in Pregnancy
RECRUITING · NA
-
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
RECRUITING · Phase 2
-
Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching
RECRUITING · NA
-
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
RECRUITING · Phase 4
-
Early Detection of Gestational Diabetes Mellitus in Pregnancy
RECRUITING · NA
-
Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03422731 · 74 participants · Early Phase 1
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
- NCT03804853 · 74 participants · NA
Rehabilitation Following Reverse Total Shoulder Arthroplasty
- NCT04065776 · 74 participants · NA
Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma
- NCT04771156 · 74 participants · Phase 4
Ketorolac in Palatoplasty
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia