Comparing a Novel Point-of-care Cytokine Biomarker Lateral Flow Test With Nucleic Acid Amplification Tests for Detection of Sexually Transmitted Infections and Bacterial Vaginosis
DIAGNOSTIC Study Design: The study is a multicentre, multidisciplinary, cross sectional, prospective clinically based research project. The first component is a diagnostic study which will enrol 225 women attending family planning services in each of the three study sites in South Africa, Zimbabwe, and Madagascar. Vaginal samples from the women will be applied to the GIFT device and results will be compared with the composite NAAT reference test for STIs and Nugent score test for BV to determine the performance of the device to detect STIs/BV. Women will attend only one study visit but will be recalled for treatment if required. The second component to develop a feasible, acceptable and economically feasible STI/BV management algorithm which includes the use of the GIFT device to be integrated into national guidelines (hereafter referred to as the "integration study") is composed of four activities with different study designs: 1.User experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews, and a quantitative questionnaire for health care professionals; 2. Discrete choice experiment; 3 Development of a decision tree classification algorithm; 4. Economic evaluation of the defined management algorithms. Study Sites: 1. Cape Town, South Africa; Desmond Tutu Health Foundation (DTHF) Masiphumelele 2. Harare, Zimbabwe; Chitungwiza Primary Health Care Clinics 3. Antananarivo, Madagascar; Centre Hospitalier Universitaire Gynéco-Obstétrique de Befelatanana Diagnostic Device: The GIFT device is an immune-based lateral flow test for reproductive-aged, non-pregnant in resource-limited settings attending sexual reproductive health (family planning) clinics, community health centers, hospitals, and mobile clinics. The test involves the qualitative detection of genital inflammation caused by asymptomatic STIs and BV in self- or clinician-collected lateral vaginal wall swabs, with results available in less than 20 minutes. Diagnostic Study Objectives: Primary objectives To assess the sensitivity and specificity of the GIFT device at the point-of-care in non-pregnant sexually active women aged 18-35 years accessing family planning services in South Africa, Zimbabwe, and Madagascar. Secondary objectives To assess the predictive values of the GIFT device at the point-of-care in non-pregnant sexually active women aged 18-35 years accessing family planning services in South Africa, Zimbabwe, and Madagascar; To assess the performance of the GIFT device at the point-of-care in non-pregnant sexually active women aged 18-35 years accessing family planning services in each of the countries; To assess the performance of the device versus syndromic management without any laboratory testing (standard of care in South Africa, Zimbabwe, and Madagascar); To determine the robustness of the device by comparing results read by clinicians with those read by laboratory professionals, and with the results obtained using an automated reader; To evaluate the accuracy of the GIFT device by comparing the GIFT device results with ELISA (enzyme-linked immunosorbent assay) results using previously validated concentration cut-offs as the gold standard, including validation of the GIFT cytokine concentration cut-offs for each cytokine biomarker. Exploratory objectives Determine if other determinants (such as intermediate microbiota (Nugent 4-6), age, parity, sexual activity) improve the prediction of STI/BV status in women; To use 16S rRNA gene sequencing and vaginal bacteria specific quantitative NAATs to evaluate the proportion of cases of genital inflammation explained by vaginal dysbiosis that was not diagnosed as an STI or BV by NAATs or Nugent scoring; To explore the performance of the device in the presence of vaginal Candida spp colonisation. INTEGRATION Study To evaluate how the GIFT device can be integrated in a feasible, acceptable, and cost-effective way into routine care (the "integration study"), four activities will be conducted: 1. User experiences and/or perceptions of the GIFT device; 2. Discrete choice experiment; 3 Development of a decision tree classification algorithm; 4. Economic evaluation of the defined management algorithms. Objectives: Primary objective To evaluate how the GIFT device could be integrated into routine care. Secondary objectives To qualitatively and quantitatively assess the user-experience, usability, and acceptability of the GIFT device at the point of care; To examine patient preferences for various STI management aspects (attributes) to inform the development of STI management algorithms that integrate the GIFT device; To generate algorithms that integrate the GIFT device to optimise case finding and STIs/vaginal infection management in women, using the complete dataset from the study; To determine the cost and budget impact of the identified screening or diagnostic algorithm with the GIFT device, and to model the cost- effectiveness of different strategies of integration of GIFT into care.
Phase
N/ASpan
83 weeksSponsor
University of Cape TownRecruiting
GERD Infant Feeding Therapeutics Trial (GIFT Trial)
In consented subjects, eligibility is determined after initial diagnostic 24-hour pH Impedance test. These subjects will be randomized to one of the 3 arms of the study (natural maturation, PPI, AR formula) for 4 weeks of treatment. A second 24-hour pH Impedance test will be done on therapy at 4 weeks or before discharge, whichever occurs first. Primary outcome will also be measured at 4 weeks or at discharge, whichever comes first.
Phase
N/ASpan
246 weeksSponsor
Nationwide Children's HospitalRecruiting
Pharmacy-based PrEP for Young Women Who Sell Sex in Zimbabwe
Phase
N/ASpan
93 weeksSponsor
University of California, BerkeleyRecruiting
Healthy Volunteers
Kidney Health: Eat Well, Live Well
This study tests a community-based program aimed at supporting adults with early-stage chronic kidney disease to change their eating habits to reduce the likelihood of kidney injury progression. The program components were design to reduce barriers to a) eating healthier, kidney-friendly foods through the direct provision of fruits and vegetables, grocery store e-gift cards, kidney-friendly recipes, and food preparation tips; b) learning about kidney disease and the role of healthy eating in slowing its progression through educational materials; and c) social connection through empathetic relational phone calls and SMS texts from a dedicated "Health Partner". Over a period of 6 months (26 weeks), participants randomized to the intervention arm will receive: - kidney-friendly produce (fruits and vegetables) delivered at their preferred location - recipes and tips on food preparation tailored to the produce - grocery store electronic gift cards - educational materials on CKD and disease management - personalized practical and emotional support through a dedicated Health Partner Researchers will see if participation in the program (intervention) reduces markers of kidney injury (Albumin:Creatinin ratio) and cardiovascular disease risk and improves diet (particularly fruits and vegetables intake) and mental health when compared to usual care (control).
Phase
N/ASpan
130 weeksSponsor
University of Texas at AustinRecruiting