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STI Screening for Women With Disabilities in Zambia

StatusCompleted
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
The goal of this observational study is to assess the prevalence of sexually transmitted infections (STIs), mental health disorders, and substance abuse among women with physical and psychosocial disabilities in Lusaka, Zambia, while exploring the intersectional factors that influence their access to healthcare services and health-seeking behaviors. The study targets women aged 18-49 years living with disabilities, a population historically excluded from STI surveillance and care despite facing heightened vulnerabilities. With approximately 376 million new curable STI cases occurring globally annually, women with disabilities face disproportionately higher risks due to biological vulnerabilities, socioeconomic disadvantages, and structural barriers. In sub-Saharan Africa, STI prevalence among women ranges from 8.5% to 32.7%, with evidence suggesting even higher rates among women with disabilities. In Zambia, disability prevalence is estimated at 29.9%, and women with disabilities have a 2.21-fold higher likelihood of HIV infection during antenatal care compared to the general population. Despite these statistics, a critical data gap exists regarding STI burden among Zambian women with disabilities. Existing research focuses on HIV in the general population, neglecting CT/NG, syphilis, and cervical cancer in disabled women. Women with disabilities encounter numerous barriers including physical inaccessibility, provider biases, 50% less sexual health education, higher rates of risky sexual behavior, stigma, and 3-4 times higher likelihood of sexual violence. Most health facilities lack disability-inclusive amenities, discouraging service access and leaving infection burden unknown. Target population includes women aged 18-49 years with physical and psychosocial disabilities residing in Lusaka district. Purposive sampling will recruit participants. Inclusion criteria: women aged 18+ with confirmed disability (WHO Assessment Schedule), willing to provide informed consent, sexually active within the past 12 months. Exclusion criteria: women without disabilities, cognitive disabilities, unable to provide consent, severely ill/hospitalized. Minimum sample size of 150 participants calculated at 95% CI with 5% margin of error, adjusted by 10% for nonresponse (target \~165 participants). At the end of the study, STI prevalence will be documented , providing comprehensive data on infection burden; quantification of anxiety, depression, and substance abuse prevalence with associations to STI status. Research Assistants and sign-language interpreters conduct health education at the recruitment site and assess eligibility. Women expressing interest are consented, after which the Research Assistants administer the WHODAS questionnaire collecting sociodemographic and disability-related data. Additionally, they will collect data on quality of life (EQ-5D-5L) and mental health status - anxiety, depression (PHQ-5), post traumatic stress disorders (PC-PTSD-5), and substance abuse (ASSIST). Women will then be transported to a health facility for Chlamydia and Gonorrhoea screening by collecting a vaginal swab for testing on GeneXpert™. At the same time, women will be screened for Cervical Cancer using Visual Inspection with Acetic Acid (VIA). Positive lesions may prompt same-day LEEP or cryotherapy. Women will also be tested for HIV/Syphilis using the Rapid point-of-care test (Bioquick™ HIV/Syphilis Duo) using venous blood, results in 10-20 minutes. Positive STI results will prompt same day treatment and partner referral. Women identified with severe mental health conditions will be referred for further management. Data will be collected on a tablet and submitted to a database created in RedCap with automated range/consistency checks. Data reviews will be conducted daily. Analysis includes descriptive statistics, prevalence with 95% exact confidence intervals, unadjusted prevalence ratios, and multivariable logistic regression using backward selection (significance set at 0.05). Ethical approval will be obtained from UNZABREC and NHRA. Informed consent will be provided in private settings. Participants may withdraw consent at any time. Risks are minimal (speculum discomfort, mild cramping, possible bleeding) and managed with standard protocols. Privacy will be protected through anonymization, study ID assignment, locked cabinets, and restricted access. Participants receive counseling on the importance of partner notification. Adverse events and protocol deviations will be reported per UNZABREC requirements.
Trial Details
NCT Number NCT07865234
Lead Sponsor Centre for Infectious Disease Research in Zambia
Conditions
(from sponsor)
Sexually Transmitted Infections, Women With Disabilities, Mental Health Conditions
Related terms Psychological Well-Being, Sexually Transmitted Diseases, Substance-Related Disorders, Uterine Cervical Neoplasms
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov