Dual Rapid HIV & Syphilis Tests in Zambia

NCT02445846 | Completed

• 1 other identifier: 14-0528
• Study Type: observational
• Target: 3,010
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Syphilis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• acceptability of use of dual rapid HIV/syphilis tests

  day 1/enrollment

Study Arms (1)

Pregnant women

Pregnant women, regardless of HIV status, seeking antenatal care at clinics in Lusaka, Zambia

Device: dual HIV/syphilis rapid diagnostics tests

Interventions

dual HIV/syphilis rapid diagnostics tests DEVICE

Also known as: Chembio and Standard Disgnostics

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women, regardless of HIV status, seeking antenatal care at Chipata, Chawama, or Kamwala District Health Centres in Lusaka, Zambia.

You may qualify if:

• Pregnant women attending their first antenatal care visit at a study clinic
• years of age or older
• Willing and able to provide informed consent for study participation

You may not qualify if:

• Prior participation in the study

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• World Health Organization: collaborator

Study Sites (1)

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Location

Related Publications (12)

• 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.

  PMID: 21943308 BACKGROUND

• 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.

  PMID: 21330572 BACKGROUND

• 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.

  PMID: 9989893 BACKGROUND

• 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.

  PMID: 16954728 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12232834 BACKGROUND

• 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.

  PMID: 12232835 BACKGROUND

• 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.

  PMID: 10023347 BACKGROUND

• 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.

  PMID: 8313495 BACKGROUND

• 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.

  PMID: 17592385 BACKGROUND

• 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.

  PMID: 22820810 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Margaret Kasaro, MBChB, MSc

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 15, 2015
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 21, 2017

Record last verified: 2017-02

Locations

ZA (1)