HIVNCT02445846

Dual Rapid HIV & Syphilis Tests in Zambia

An observational study of HIV and Syphilis, run by University of North Carolina, Chapel Hill at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: HIV, Syphilis
What is being tested?: dual HIV/syphilis rapid diagnostics tests
Type of treatment: Medical device
How many people: 3,010 participants
Where: 1 siteZambia
Study dates: May 2014to Jan 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

Prior participation in the study

Trial locations and contacts

1 site in 1 country.

Zambia1 site

Centre for Infectious Disease Research in Zambia
Lusaka

Other trials in Zambia

About this study

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

Read the detailed 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.

Conditions: HIV, Syphilis
Being tested: dual HIV/syphilis rapid diagnostics tests
Medical subject headings: Syphilis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dual HIV/syphilis rapid diagnostics testsDevice
Also called Chembio and Standard Disgnostics

Study groups in NCT02445846
Study group	Role	What they receive
Pregnant women		Pregnant women, regardless of HIV status, seeking antenatal care at clinics in Lusaka, Zambia Receives: Device: dual HIV/syphilis rapid diagnostics tests

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: day 1/enrollment

Secondary outcomes (1)

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.
Measured: day 1/enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jan 2016

First posted15 May 2015 (estimated)
Study startMay 2014
Primary completionDec 2015
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 3,010 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02445846
Sponsor's protocol ID: 14-0528
Status last verified: Feb 2017
First submitted: 13 May 2015
Last updated: 21 Apr 2017
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 21943308
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.
PubMed 21330572
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.
PubMed 9989893
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.
PubMed 16954728
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.
PubMed 12232834
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.
PubMed 12232835
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.
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.
PubMed 8313495
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.
PubMed 17592385
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.
PubMed 22820810
Kettler H, White K, Hawkes S. Mapping the landscape of diagnostics for sexually transmitted infections. World Health Organization, Geneva, 2004.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Field Performance Evaluation of Dual Rapid HIV & Syphilis Tests in Zambia
ClinicalTrials.gov ID: NCT02445846
Acronym / sponsor ID: 14-0528
Conditions: HIV, Syphilis
Study type: Observational
Recruitment status: Completed
Enrolment: 3,010 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: World Health Organization
Study start: May 2014 (actual)
Primary completion: Dec 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 15 May 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Pregnant women	–	Device: dual HIV/syphilis rapid diagnostics testsPregnant women, regardless of HIV status, seeking antenatal care at clinics in Lusaka, Zambia

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Pregnant women, regardless of HIV status, seeking antenatal care at Chipata, Chawama, or Kamwala District Health Centres in Lusaka, Zambia.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Prior participation in the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dual HIV/syphilis rapid diagnostics testsAlso: Chembio and Standard Disgnostics	Device	Pregnant women

Primary outcome

performance of dual rapid HIV/syphilis tests
Time frame: day 1/enrollment
The performance of the rapid study tests will be assessed by determining the specificity and the sensitivity when compared to reference standard assays

1 secondary outcome

acceptability of use of dual rapid HIV/syphilis tests
Time frame: day 1/enrollment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
Background: PubMed 21943308Katepa-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.
Background: PubMed 21330572Kalichman 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.
Background: PubMed 9989893Lee 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.
Background: PubMed 16954728Mwapasa 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.
BackgroundWHO. 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: PubMed 12232834Watson-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.
Background: PubMed 12232835Watson-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.
BackgroundWHO. 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.
Background: PubMed 8313495McDermott 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.
Background: PubMed 17592385Di 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.
Background: PubMed 22820810Strasser 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.
BackgroundKettler H, White K, Hawkes S. Mapping the landscape of diagnostics for sexually transmitted infections. World Health Organization, Geneva, 2004.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margaret Kasaro, MBChB, MSc principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV and Syphilis, run by University of North Carolina, Chapel Hill at 1 site in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

performance of dual rapid HIV/syphilis tests (time frame: day 1/enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02445846, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.