Loading search results
From Exclusion to Equity: Sexually Transmitted Infections and Mental Health Screening Among Women With Disabilities in Lusaka, Zambia: A Pilot Study
Sponsor study identifier
observational
150
1 country
1
Study Start
May 4, 2026
Actual (reported)Primary Completion
June 26, 2026
Actual (reported)Study Completion
June 26, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 26, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 4, 2026
Actual (reported)June 26, 2026
Actual (reported)June 26, 2026
Actual (reported)September 15, 2026
Actual (reported)October 8, 2026
Actual (reported)Prevalence of Sexually Transmitted Infections (STIs) among women with disabilities
Prevalence of CT/NG, HIV, Syphilis and cervical precancerous cancer
1 year
Prevalence of Depression
1 year
Health-related quality of life
1 year
Prevalence of anxiety
The target population includes 150 women aged 18-49 years living with physical and psychosocial disabilities residing in Lusaka District. Women willing to participate will be recruited using a purposive sampling technique. The inclusion criteria is: women with confirmed disability, sexually active in the last 3 months, and willingness to participate.
The target population includes women aged 18-49 years living with physical and psychosocial disabilities residing in Lusaka District. Women willing to participate will be recruited using a purposive sampling technique.
Kanyama 1st Level Hospital
Lusaka, Lusaka Province, 10101, Zambia
Swinson RP. The GAD-7 scale was accurate for diagnosing generalised anxiety disorder. Evid Based Med. 2006 Dec;11(6):184. doi: 10.1136/ebm.11.6.184. No abstract available.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Banks LM, Kuper H, Polack S. Correction: Poverty and disability in low- and middle-income countries: A systematic review. PLoS One. 2018 Sep 26;13(9):e0204881. doi: 10.1371/journal.pone.0204881. eCollection 2018.
150 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2026
First Posted
October 8, 2026
Study Start
May 4, 2026
Actual (reported)1 year
Prevalence of PTSD
1 Year
Prevalence of Cervical Precancerous Lesions
1 Year
Contact the study team to confirm eligibility.
Vallely LM, Kapungu K, Mengi A, Chaponda M, Chico RM, Riddell MA, Vallely AJ, Pomat W, Cignacco E, Low N, Kelly-Hanku A. The prioritisation of curable sexually transmitted infections among pregnant women in Zambia and Papua New Guinea: Qualitative insights. PLOS Glob Public Health. 2024 Jul 25;4(7):e0003441. doi: 10.1371/journal.pgph.0003441. eCollection 2024.
Scherer N, Chabaputa R, Chansa-Kabali T, Nseibo K, McKenzie J, Banda-Chalwe M, Smythe T. Access to healthcare for people with disabilities in Zambia: a qualitative study. PLOS Glob Public Health. 2025 Mar 31;5(3):e0004145. doi: 10.1371/journal.pgph.0004145. eCollection 2025.
Chipanta D, Stockl H, Toska E, Amo-Agyei S, Chanda P, Mwanza J, Kaila K, Matome C, Tembo G, Thiabaud A, Keiser O, Estill J. Women with disabilities in hearing: the last mile in the elimination of mother-to-child transmission of HIV - a cross-sectional study from Zambia. AIDS Care. 2022 Sep;34(9):1203-1211. doi: 10.1080/09540121.2021.1998313. Epub 2021 Nov 17.
Parekh T, Gimm G, Kitsantas P. Sexually Transmitted Infections in Women of Reproductive Age by Disability Type. Am J Prev Med. 2023 Mar;64(3):393-404. doi: 10.1016/j.amepre.2022.10.013. Epub 2022 Dec 15.
Primary Completion
June 26, 2026
Actual (reported)Study Completion
June 26, 2026
Actual (reported)Last Updated
October 8, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: