Dual Rapid HIV & Syphilis Tests in Zambia

HIV Clinical Trial

Official title:

Field Performance Evaluation of Dual Rapid HIV & Syphilis Tests in Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445846
• Other study ID #: 14-0528
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: April 20, 2017
• Start date: May 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to provide evidence on the performance and operational characteristics of commercially available dual HIV/syphilis Rapid Diagnostic Tests (RDTs) in Zambia for their introduction into antenatal care and other settings.

Description:

Early detection and timely intervention of pregnant women infected with HIV and/or syphilis is critical. To improve the number of women tested and treated, the Centre for Infectious Disease Research in Zambia (CIDRZ) and the Ministry of Community Development, Mother and Health (MCDMCH) this field study will assess the effectiveness of newly developed dual HIV and syphilis rapid diagnostic tests (RDTs) manufactured by Chembio and Standard Diagnostics in Lusaka District antenatal clinics.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3010
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women attending their first antenatal care visit at a study clinic

• 18 years of age or older

• Willing and able to provide informed consent for study participation

Exclusion Criteria:

• Prior participation in the study

Related Conditions & MeSH terms

• HIV
• Syphilis

Intervention

Device:
• dual HIV/syphilis rapid diagnostics tests

Locations

Country	Name	City	State
Zambia	Centre for Infectious Disease Research in Zambia	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	World Health Organization

Country where clinical trial is conducted

Zambia, 

References & Publications (12)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Kettler H, White K, Hawkes S. Mapping the landscape of diagnostics for sexually transmitted infections. World Health Organization, Geneva, 2004.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Watson-Jones D, Changalucha J, Gumodoka B, Weiss H, Rusizoka M, Ndeki L, Whitehouse A, Balira R, Todd J, Ngeleja D, Ross D, Buvé 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. Epub 2002 Sep 3. — View Citation

Watson-Jones D, Gumodoka B, Weiss H, Changalucha J, Todd J, Mugeye K, Buvé 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. Epub 2002 Sep 3. — View Citation

WHO. Global prevalence and incidence of selected curable sexually transmitted infections. Overview and estimates. Geneva: http://www.who.int/hiv/pub/sti/who_hiv_aids_2001.02.pdf. Accessed April 1, 2011.

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.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	performance of dual rapid HIV/syphilis tests	The performance of the rapid study tests will be assessed by determining the specificity and the sensitivity when compared to reference standard assays	day 1/enrollment
Secondary	acceptability of use of dual rapid HIV/syphilis tests	the operational characteristics and acceptability of the tests to patients and health care providers will be measured.	day 1/enrollment