Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
3010 participants
OBSERVATIONAL
2014-05-31
2016-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe
NCT05541081
Point of Care Tests for Syphilis and HIV
NCT04514848
Nucleic Acid Amplification Tests (NAATs) for the Diagnosis of Pharyngeal and Rectal Chlamydia and Gonorrhea Infections
NCT00252096
STD Testing in Outpatient Practices
NCT03246815
Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT
NCT02870101
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The specific objectives of this field performance evaluation of the rapid diagnostics are to determine the antenatal clinic-based performance of dual HIV/syphilis RDTs compared to that of current reference standard assays, and to assess the operational characteristics and acceptability of these dual HIV/syphilis RDTs to patients and health care providers This cross-sectional study of 3,765 pregnant women will validate the performance of Chembio and Standard Diagnostics dual HIV and Syphilis RDTs.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pregnant women
Pregnant women, regardless of HIV status, seeking antenatal care at clinics in Lusaka, Zambia
dual HIV/syphilis rapid diagnostics tests
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dual HIV/syphilis rapid diagnostics tests
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 years of age or older
* Willing and able to provide informed consent for study participation
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
World Health Organization
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Margaret Kasaro, MBChB, MSc
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre for Infectious Disease Research in Zambia
Lusaka, , Zambia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Katepa-Bwalya M, Kankasa C, Babaniyi O, Siziya S. Effect of using HIV and infant feeding counselling cards on the quality of counselling provided to HIV positive mothers: a cluster randomized controlled trial. Int Breastfeed J. 2011 Sep 26;6:13. doi: 10.1186/1746-4358-6-13.
Kalichman SC, Pellowski J, Turner C. Prevalence of sexually transmitted co-infections in people living with HIV/AIDS: systematic review with implications for using HIV treatments for prevention. Sex Transm Infect. 2011 Apr;87(3):183-90. doi: 10.1136/sti.2010.047514. Epub 2011 Feb 17.
Lee MJ, Hallmark RJ, Frenkel LM, Del Priore G. Maternal syphilis and vertical perinatal transmission of human immunodeficiency virus type-1 infection. Int J Gynaecol Obstet. 1998 Dec;63(3):247-52. doi: 10.1016/s0020-7292(98)00165-9.
Mwapasa V, Rogerson SJ, Kwiek JJ, Wilson PE, Milner D, Molyneux ME, Kamwendo DD, Tadesse E, Chaluluka E, Meshnick SR. Maternal syphilis infection is associated with increased risk of mother-to-child transmission of HIV in Malawi. AIDS. 2006 Sep 11;20(14):1869-77. doi: 10.1097/01.aids.0000244206.41500.27.
WHO. Progress Report 2010; Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector; Chapter 5: Scaling Up HIV Services for Women and Children http://www.who.int/hiv/pub/2010progressreport/ch5_en.pdf. Accessed July 12, 2011.
Watson-Jones D, Changalucha J, Gumodoka B, Weiss H, Rusizoka M, Ndeki L, Whitehouse A, Balira R, Todd J, Ngeleja D, Ross D, Buve A, Hayes R, Mabey D. Syphilis in pregnancy in Tanzania. I. Impact of maternal syphilis on outcome of pregnancy. J Infect Dis. 2002 Oct 1;186(7):940-7. doi: 10.1086/342952. Epub 2002 Sep 3.
Watson-Jones D, Gumodoka B, Weiss H, Changalucha J, Todd J, Mugeye K, Buve A, Kanga Z, Ndeki L, Rusizoka M, Ross D, Marealle J, Balira R, Mabey D, Hayes R. Syphilis in pregnancy in Tanzania. II. The effectiveness of antenatal syphilis screening and single-dose benzathine penicillin treatment for the prevention of adverse pregnancy outcomes. J Infect Dis. 2002 Oct 1;186(7):948-57. doi: 10.1086/342951. Epub 2002 Sep 3.
Gerbase AC, Rowley JT, Heymann DH, Berkley SF, Piot P. Global prevalence and incidence estimates of selected curable STDs. Sex Transm Infect. 1998 Jun;74 Suppl 1:S12-6.
McDermott J, Steketee R, Larsen S, Wirima J. Syphilis-associated perinatal and infant mortality in rural Malawi. Bull World Health Organ. 1993;71(6):773-80.
Di Mario S, Say L, Lincetto O. Risk factors for stillbirth in developing countries: a systematic review of the literature. Sex Transm Dis. 2007 Jul;34(7 Suppl):S11-21. doi: 10.1097/01.olq.0000258130.07476.e3.
Strasser S, Bitarakwate E, Gill M, Hoffman HJ, Musana O, Phiri A, Shelley KD, Sripipatana T, Ncube AT, Chintu N. Introduction of rapid syphilis testing within prevention of mother-to-child transmission of HIV programs in Uganda and Zambia: a field acceptability and feasibility study. J Acquir Immune Defic Syndr. 2012 Nov 1;61(3):e40-6. doi: 10.1097/QAI.0b013e318267bc94.
Kettler H, White K, Hawkes S. Mapping the landscape of diagnostics for sexually transmitted infections. World Health Organization, Geneva, 2004.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14-0528
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.