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Table 1 Table of studies included in review detailing information on study design, context, and measures of acceptability

From: Facilitators and barriers to point-of-care testing for sexually transmitted infections in low- and middle-income countries: a scoping review

Authors (year)

STI

Study design

Country

Setting

Study population

POCT used

Sample used & collection method

How integrated into care

Acceptability (client testing uptake)

Measures of feasibility

Antenatal care only

Watson-Jones et al. (2005) [23]

TP

Multi-study data synthesis

Tanzania

ANC (mixed urban/rural)

Pregnant women

RPR

Venous blood

Integrated into routine care

Poor feasibility demonstrated

Many facilities were failing to implement syphilis screening effectively

During clinical observations of 342 ANC attenders across 9 sites, only 39% were either tested for syphilis or booked for testing

Only 970/2256 eligible ANC attenders (43%) over 4 months were documented as receiving an RPR test. Of 144 (15%) who were RPR-positive, only 88 (61%) were treated and 53 (37%) had a sexual contact who attended the clinic for treatment

Only 10% of 110 interviewed staff who were consulting with patients and likely to assess prenatal clients had received training in performing the RPR test

Ansbro et al. (2015) [24]

TP

Qualitative

Zambia

ANC (mixed urban/rural)

HCWs (ANC)

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

93.8% (15/16) of pilot HCWs and 62.5% (15/24) of rollout HCWs thought patients were accepting of the RST

Most HCWs agreed RSTs were successfully integrated into facility PMTCT services (16/16 pilot, 23/24 rollout HCWs)

Dassah et al. (2015) [25]

TP

Interrupted time series (before-after)

Ghana

ANC (mixed urban/rural)

Pregnant women

Fingerprick blood

Integrated into routine care

Almost all health facilities that were previously not screening pregnant women for syphilis had absolute increases in AST uptake, following the rollout

However, all other facilities bar one that performed AST in 2009 had an absolute reduction in AST uptake in 2010

AST uptake of 50.0% and 33.6% in 2009 and 2010, respectively, thus leading to a much larger decrease (16.4%) in estimates of uptake following POCT rollout

Vani et al. (2015) [26]

TP

Qualitative

India

ANC (mixed urban/rural)

Key stakeholders at facility, state, and district level

Integrated into routine care

HCWs reported that POCT would be feasible if finger prick

Maddox et al. (2017) [27]

TP

Qualitative

Malawi

ANC (mixed urban/rural)

HCWs, laboratorians, Ministry of Health leaders and partner agency representatives

Chembio Dual Path Platform HIV-Syphilis Assay

Alere Determine Syphilis TP*

Fingerprick blood

Stakeholders viewed the dual RDT as a feasible alternative to the standard tests for use in the ANC setting, although some concerns over the complexity of the dual test

Dassah et al. (2018) [28]

TP

Qualitative

Ghana

ANC (mixed urban/rural)

HCWs

Alere Determine Rapid Syphilis TP

Fingerprick blood

Integrated into routine care

Decentralisation of syphilis testing and provision of free syphilis testing and treatment appeared successful

The main successes of the rollout programme were reported to be easy integration of syphilis screening into ANC services and its decentralisation to most public health facilities

Kanyangarara et al. (2018) [29]

TP

Secondary data analysis

DRC, Kenya, Malawi, Tanzania, Uganda, Zimbabwe, Benin, Burkina Faso, Mauritania, Senegal, Sierra Leone, Togo

ANC (mixed urban/rural)

Health facilities offering ANC

Integrated into routine care

Diagnostic capacity for syphilis at health facilities offering ANC varied across countries, ranging from 3% in Burkina Faso to 92% in Zimbabwe

One in twelve women received ANC at a facility ready to provide syphilis detection and treatment during the first 3 months of pregnancy

One in ten women received ANC during the first 3 months of pregnancy at a facility ready to provide syphilis screening

Olugbenga et al. (2018) [30]

TP

Field evaluation

Nigeria

ANC (mixed urban/rural)

Pregnant women

SD BIOLINE HIV/Syphilis Duo

Fingerprick blood

Standalone project. POCT results determine treatment

99.9% preferred dual RDT compared to single tests for HIV and syphilis

Clinic staff rated the dual RDT with an overall feasibility score 12.3/16 [Clarity of kit instruction = 2.39/3; Ease of use = 2.41/3; Ease of interpretation of results = 2.27/3; Rapidity of test results = 1.91/2; Hands-on time 1.356; Training time required = 1.95/3]

Garcia et al. (2007) [31]

TP

Implementation Study

Bolivia

ANC (mixed urban/rural)

Pregnant women

Abbott Determine Rapid Syphilis TP

Fingerprick blood

Standalone project. POCT results determine treatment

Study participants reported that they found the test highly acceptable

577/11618 (5.0%) tested positive by syphilis RDT test

93.2% (538/577) received at least a single dose of penicillin, and 81.5% (n = 470) received all three recommended doses

Bolivian health policy directly influenced by study—The Ministry of Health added syphilis screening with RDTs to the national maternal health guidelines

Severe et al. (2013) [32]

TP

Time-series implementation study

Haiti

ANC (mixed urban/rural)

Pregnant women

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

Pre-POCT: 91.5% (31,810/34,776)

Post-POCT: 95.9% (15,373/16,025)

Post-QI intervention: 96.8%

(15,916/16,435)

High rates of testing across all time periods

Syphilis treatment only increased from 70.3 to 74.7% after the introduction of rapid tests (p = 0.28), but it improved significantly from 70.2 to 84.3% (p < 0.001) after the systems strengthening QI intervention

Bonawitz et al. (2015) [33]

TP

Quasi-experimental evaluation

Zambia

ANC (mixed urban/rural)

Pregnant women

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

Baseline: 10.3% screened for syphilis by RPR testing

Midline: 67.5% screened (p < 0.001)

Endline 56.3% screened (p < 0.001)

Dassah et al. (2015) [34]

TP

Case control

Ghana

ANC (mixed urban/rural)

Pregnant women

Integrated into routine care

Bocoum et al. (2017) [35]

TP

Mixed methods evaluation

Burkino Faso

ANC (mixed urban/rural)

Pregnant women

Alere Determine Syphilis TP

Fingerprick blood

Integrated into routine care

Good acceptability. Few refusals recorded

Only 39% of eligible pregnant women underwent screening, likely due to stock outs

HCWs reported that the test was easy to use given its similarity to pre-existing HIV tests

Wang et al. (2018) [36]

TP

Implementation study

China

ANC (mixed urban/rural)

Pregnant women

Dual HIV/Syphilis RDT—type not specified

Fingerprick or venous blood

Standalone project. POCT results required confirmation

97.8% (1787/1828)

Feasible. Among 1787 pregnant women who received RDT tests, 98.3% (1757/1787) participants were given their test result the same day

Among 1757 pregnant women received RDT testing results, 54.9% (965/1757) receiving their RDT results within 30 min, 20.7% (364/1757) received results within 30–60 min and 428 (24.4%) received results longer than 1 h later

Strasser et al. (2012) [37]

TP

Pre-post interventional study

Uganda, Zambia

ANC/PMTCT (mixed urban/rural)

Pregnant women and their male partners

SD BIOLINE Syphilis 3.0

Fingerprick or venous blood

Integrated into routine care

Zambia

Baseline: 79.9% (12,761/15,967)

Intervention: 95.6% (11,460/11,985)

Uganda

Baseline: 1.7%

Intervention: 90.3% (13,131/14,540)

RST testing was easily incorporated into services with no negative effects noted on other services

Zambia:

Baseline—51.1% (267/523) syphilis-positive women treated. Intervention—95.2% (1000/1050) treated [958 on same day]

Uganda:

Intervention—5.3% (690/13,131) were positive and 103.6% (715/690) treated [Women who tested syphilis-negative but whose partner tested positive were treated, resulting in over 100% of positive cases in women treated, 708 of 715 (99.0%) of those treated received on same day

No adverse effects noted on other services, and significant increases noted in percentages of pregnant women testing for HIV and receiving antiretroviral prophylaxis

Mabey et al. (2012) [38]

TP

Multi-country implementation study

Tanzania, Uganda, Zambia, China, Peru, Brazil

ANC (mixed urban/rural), community-based screening (in Amazon)

Pregnant women & sexually active population (in Amazon)

Brazil/Peru/Tanzania/Uganda/Zambia: SD Bioline Syphilis 3.0

China: Wantai anti-TP Antibody Rapid Test

Fingerprick blood

Integrated into routine care

78.1% (150,068/192,140) screened

The proportion of ANC attenders screened for syphilis increased to > 90%, and the proportion of pregnant women with syphilis who were treated the same day exceeded 90% in all countries

In Brazil, HCWs in remote communities succeeded in screening 55% of the sexually active population for syphilis, exceeding the 30–40% target originally set

All six countries changed their policy to recommend the use of rapid tests to provide a STAT service

Wilkinson & Sach (1998) [39]

TP

Intervention study

South Africa

ANC (mobile clinics/rural)

Pregnant women

RPR

Venous blood

Integrated into routine care

100% (398/398)

Following introduction of on-site testing, 51 of 68 women (75%) with a positive RPR test received all three doses of penicillin, compared with 22 of 45 women (49%) when testing was done in the laboratory (p = 0.004)

The mean number of penicillin doses received by RPR positive women increased from 1.9 to 2.6 (p = 0.0003)

Far fewer women received no or only one penicillin dose (8/68, 11.7%) when testing was done on-site than when it was laboratory-based (13/45, 28.9%; p = 0.02)

With on-site testing all women received at least one penicillin dose, whereas with laboratory testing 10 (22.2%) did not receive any treatment (p = 0.0001)

Smith et al. (2015) [40]

TP

Implementation study

Guatemala

ANC (rural outreach service)

Pregnant women

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

50.3% (901/1793)

Antenatal care coverage in public healthcare services increased from 73.7 to 99.6% before and after introduction of the outreach screening program

Syphilis screening increased from 49.6 to 50.3% (p = 0.87)

Syphilis prevalence = 8/901 (0.89%). All syphilis cases were confirmed, treated, and their partners notified

Myer et al. (2003) [41]

TP

Cluster RCT

South Africa

ANC (rural)

Pregnant women

RPR

Venous blood

Standalone project. POCT results determine treatment

Mixed feasibility—No significant difference in outcomes between intervention and control clinics

Nurses at busy intervention clinics frequently had difficulty in conducting the on-site test, informing women of their infection, and initiating treatment. Supply chain issues for testing materials

On-site results available for 94.9% (4754/5011) eligible women

The average time from the first antenatal visit to the completion of syphilis treatment was 16 days shorter for women attending intervention clinics compared to those attending control clinics (95% CI 11–21, p < 0.001)

Similar proportions received no treatment (20% v 19%) and adequate treatment (64% v 69%)

3.3% of pregnancies resulted in perinatal death among women attending intervention clinics, compared with 5.1% among women attending control clinics (p = 0.31)

Bronzan et al. (2007) [42]

TP

Non-randomised trial

South Africa

ANC (rural)

Pregnant women

RPR

Abbott Determine Rapid Syphilis TP

Fingerprick blood for ICS. Venous blood for on-site RPR

Standalone project but well integrated into care. POCT results determine treatment

Feasible. Significantly more women received at least one dose of penicillin at the intervention clinics with onsite testing

Intervention clinics: 89.4% (93/104) of eligible women received at least one dose of penicillin

The onsite RDT resulted in the greatest percentage of pregnant women correctly diagnosed and treated for active syphilis

Fleming et al. (2013) [43]

TP

Mixed methods

Kenya

ANC (rural)

Pregnant women

Fingerprick blood

Integrated into routine care

Pre-intervention: 18% (179/1586)

Post-intervention: 70% (1123/1614)

Evaluation suggests RDTs are feasible for use in ANC services at low-level, rural facilities

Pre-intervention: 18% (279/1586) tested

During intervention: 70% (1123/1614) tested

Increase in syphilis testing statistically significant at every facility

At the three dispensaries, testing increased from 0 to 79% of attendees

Baker et al. (2015) [44]

TP

Mixed methods

Tanzania, Uganda

ANC (rural)

Mothers in villages and healthcare key informants

Integrated into routine care

Tanzania: effective coverage of syphilis screening estimated at 15% (213/1422)

Uganda: effective coverage of syphilis screening estimated at 3% (88/2933)

Baker et al. (2015) [45]

TP

Cross-sectional

Tanzania

ANC (rural)

Women and ANC HCWs

Integrated into routine care

Estimated effective coverage of syphilis screening in Tandahimba was 12% despite near universal accessibility coverage

25% in Tandahimba and 26% in Newala received a syphilis test during ANC

De Schacht et al. (2015) [46]

TP

Quasi-experimental operational research study

Mozambique

ANC (rural)

Pregnant women, HCWs

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

Baseline coverage of syphilis screening: 80.8% (95%CI 65.3–96.2)

After introduction of POC testing: 87.0% (95%CI 76.4–97.7); p = 0.282

Variable effect of introduction of POCTs across different facilities:

Moamba and Marracuene: Significantly increased

Macia: Inititally low, and remained unchanged

Magude: Significantly decreased

No difference in time from first ANC visit to syphilis screening—same-day testing performed both before and after introduction of POC testing

Nnko et al. (2016) [47]

TP

Qualitative

Tanzania

ANC (rural)

Pregnant women

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

100% (7954/7954)

Pre-implementation, 62% (31/50) of health facilities had the capacity to screen syphilis using RPR, however, only 22.6% (7/31) did screening

Introduction of RDT doubled the number of women who attended the ANC clinics, and significantly increased the number of women who tested for syphilis at the clinics (17.9% (636/3561) vs 100% (7954/7954), p < 0.01)

Proportion of pregnant women who were found with syphilis and offered treatment increased significantly (46.3% (50/108) vs 94.8% (862/909), p < 0.01)

90.1% (5719/6345) of the positive cases from September 2009 to October 2010 were tested and treated on the same day

Kuupiel et al. (2019) [48]

TP

Cross-sectional

Ghana

ANC (rural)—PHC clinics

HCWs from PHC offering ANC

Integrated into routine care

Young et al. (2018) [49]

TP

Implementation Study

Kenya

ANC (rural)—dispensaries

Pregnant women

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

Pre-POCT: 4.3% (23/529)

Implementation: 97.6% (572/586)

Syphilis testing proportions increased from 4.3 to 97.6%

HIV testing rates remained over 90% in all facilities before and during integrated POCT period

Pre-intervention: No syphilis infections detected (0/529)

During intervention: 18 syphilis infections detected (prevalence = 3.1%)

Over 95% of participants received all four tests (HIV, syphilis, malaria, anaemia)

Young et al. (2019) [50]

TP

Qualitative

Kenya

ANC (rural)—dispensaries

HCWs and pregnant women

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

Improved client acceptability to POCT

Pai et al. (2012) [51]

TP

Cross-sectional

India

ANC (rural)—tertiary care teaching hospital

Pregnant women

Inverness Medical Determine Rapid Syphilis TP

Fingerprick blood

Standalone project. POCT results required confirmation

96.0% (1002/1066) of consented women completed testing strategy

Baseline: 8.98% (n = 90) women reported being screened for all three infections in their current pregnancy

Intervention: 96% of women screened

Bique Osman et al. (2000) [52]

TP

Cluster non-randomised trial

Mozambique

ANC (suburban)

Pregnant women

RPR

Venous blood

Standalone project. POCT results determine treatment

“Very few women declined to participate”

Feasible use of RPR in clinics—5.8% false negative and 12.8% false positive compared to lab

Munkhuu et al. (2009) [53]

TP

Feasibility study

Mongolia

ANC (urban)

Pregnant women, HCWs

SD Bioline Syphilis 3.0

Fingerprick blood

Standalone project. POCT results determine treatment

100% (246/246)

Feasible

Munkhuu et al. (2009) [54]

TP

Cluster RCT

Mongolia

ANC (urban)

Pregnant women

SD Bioline Syphilis 3.0

Fingerprick blood

Standalone project. POCT results determine treatment

POCT: 99% (3849/3850)

Control: 79.6% (3065/3850)

Feasible and more effective for the prevention of congenital syphilis

1st ANC visit: Control—79.6% tested. Intervention—Over 99% tested (p < 0.001)

3rd trimester: Control—62.1% tested. Intervention—99.7% tested (p < 0.001)

Intervention: 73 (1.9%) and 20 (0.5%) cases of syphilis detected

Control: 27(0.9%) and 2 (0.08%) cases detected

Treatment: Control—89.6% (26/29) of detected cases treated. Intervention—98.9% (92/93) of detected cases treated (p = 0.02)

Congenital syphilis: Control—15/3552 deliveries. Intervention—1/3632 deliveries (93.5% reduction, p = 0.002)

Gaitan-Duarte et al. (2016) [55]

TP

Cluster RCT

Colombia

ANC (urban)

Pregnant women

Arm A: SD Bioline Syphilis 3.0 & SD Bioline HIV 3.0

Arm B: SD Bioline HIV/Syphilis Duo

Fingerprick blood

Standalone project. POCT results determine treatment

Single tests: 99.8%

Dual test: 99.6%

In comparison to the baseline period, syphilis testing showed an increase of 9.7% in Arm A (single HIV and syphilis RDTs) and of 6.6% in Arm B (dual HIV/syphilis RDT)

Same day treatment: Single tests—69% (20/29). Dual tests—80% (16/20)

Treatment at any time: Single tests—82.8% (24/29). Dual tests—100% (20/20)

Berrueta et al. (2017) [56]

TP

Cross-sectional

DRC, Zambia

ANC (urban)

Pregnant women

DRC: Alere Determine syphilis TP

Zambia: SD Bioline Syphilis 3.0, RPR, or both

Fingerprick blood

Integrated into routine care

Overall:

DRC: 59.7% (2479/4153) Zambia: 27.8% (5025/18066)

When clinics had screening resources: DRC: 92.8% (2469/2660) Zambia: 52.0% (4761/9155)

Supplies available for screening on 78 days out of 122 in Kinshasa, and 69 days out of 129 in Lusaka

Kinshasa: 59.7% (n = 2479) screened overall. 92.8% screened when test supplies available

Lusaka: 27.8% (n = 5025) screened overall. 52.0% screened when tests supplies available

Nkamba et al. (2017) [57]

TP

Qualitative

DRC, Zambia

ANC (urban)

Pregnant women, clinic administrators, and HCWs

DRC: Alere Determine syphilis TP

Zambia: SD Bioline Syphilis 3.0

Fingerprick blood

Standalone project. POCT results determine treatment

Testing and treatment at first ANC visit acceptable to both providers and patients

Althabe et al. (2019) [58]

TP

Cluster RCT

DRC, Zambia

ANC (urban)

Pregnant women

DRC: Alere Determine Syphilis TP test

Zambia: SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

Intervention: 99.9%

Control: 93.8%

Behavioural components implemented with a compliance rate between 88 and 100% what was planned

No stockouts of supplies for screening or treatment

Kasaro et al. (2019) [59]

TP

Field evaluation

Zambia

ANC (urban)

Pregnant women

SD BIOLINE HIV/Syphilis Duo Test

Chembio Dual Path Platform HIV-Syphilis Assay

Fingerprick blood

Standalone project. No discussion of treatment

99.7% preferred the dual test over single tests

Both dual RDTs received high and similar feasibility scores from staff

Tinajeros et al. (2017) [60]

TP

Mixed methods

Bolivia

ANC (urban)

HCWs

Clinical records of pregnant women

Garcia et al. (2013) [61]

TP

Feasibility study

Peru

ANC (urban/peri-urban)

Pregnant women

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

Screening coverage: 94.8% (and remained above 92% after end of implementation period)

Feasible and improved several aspects of the health system

Treatment coverage 91.6%

Bocoum et al. (2015) [62]

TP

Field evaluation

Burkino Faso

ANC—Maternity ward at an urban PHC

HCWs working in the maternity ward at an urban PHC centre

1. Accu-Tell Rapid Anti-TP

2. Alere Determine syphilis TP

3. Cypress Diagnostics Syphilis quick test

4. SD Bioline Syphilis 3.0

Fingerprick blood

Standalone project. POCT results required confirmation

Pant Pai et al. (2019) [63]

TP

TV

Cross-sectional

India

ANC (rural outreach service)

Pregnant women

OSOM Rapid Trichomonas Test MedMira Multiplo Rapid TP/HIV antibody test

Fingerprick blood & vaginal swab

Standalone project. POCT results required confirmation

100% (510/510) consented to testing

92% (453/491) rated testing with high satisfaction

Baseline laboratory screening rates: 42% for syphilis (214/510); 0.4% for TV (2/510)

Intervention: 100% of consenting participants screened at point-of-care

Gadoth et al. (2020) [64]

CT,

NG

TV

Cross-sectional Field evaluation

DRC

ANC (mixed urban/rural)

Pregnant women

Xpert CT/NG

Xpert TV

Clinician-collected cervical swabs

Standalone project. POCT results determine treatment

99% (366/371)

9 had invalid CT/NG tests with 3 invalid TV tests

97% of positive tests were subsequently treated

Badman et al. (2016) [65]

CT

NG

TV

Descriptive feasibility study

Papua New Guinea

ANC (urban)

Pregnant women

Xpert CT/NG

Xpert TV

Self-collected vaginal swabs

Standalone project. POCT results determine treatment

Nearly all women who attended ANC requested to participate. 100% completion of study procedures amongst those enrolled

56% (125/222) of those who attended clinic enrolled due to limited testing facilities (one single, four-module, GeneXpert machine) combined with 20–15 new visits on a single day per week

All women received their test results the same day

All women with positive results had received their treatment within 1 week

Wynn (2017) [66]

CT

NG

TV

Cross-sectional

Botswana

ANC (urban)

Pregnant women

Xpert CT/NG

Xpert TV

Self-collected vaginal swabs

Standalone project. POCT results determine treatment

85.8% (400/466) enrolled

99% of participants received results either in person (61%) on the same day as testing or by phone (39%) within a week

Of 54 women with positive results: 40 received results and treated on the same day in person (74.1%), 8 received results on the same day via phone (14.8%), 5 women received delayed results and 1 woman did not receive results

Overall, 52 (96%) were treated, and 77% were treated on the same day

Wynn et al. (2016) [67]

CT

NG

TV

Prospective cohort

Botswana

ANC (urban)

Pregnant women

Xpert CT/NG

Xpert TV

Self-collected vaginal swabs

Standalone project. POCT results determine treatment

89% (200/225)

Feasible. 100% of consenting women successfully tested for CT, NG, and TV, and given their results

One sample re-tested as temperature of the Xpert machine was above the threshold

72% (n = 143) received their results in person on the day of testing

29% (n = 57) contacted by telephone, on the same day, after leaving the clinic as could not wait for their STI results

100% of women who tested positive for an STI were successfully treated, most immediately (80%)

Morikawa et al. (2018) [68]

CT

NG

TV

Field evaluation

South Africa

ANC for women living with HIV—PHC clinics (urban/peri-urban)

Pregnant women living with HIV

Xpert CT/NG

Xpert TV

Self-collected vaginal swabs

Integrated into routine care

97.3% (430/442)

91.9% (159/173) of those with a positive STI test result received same-day results and treatment

100% of women with an STI were treated within 7 days

Both antenatal care & non-antenatal settings

Bristow et al. (2017) [69]

TP

Conjoint analysis

Haiti

Health centres offering STI/HIV testing and ANC

Men and women seeking STI/HIV testing or ANC at health centres

Laksanasopin et al. (2015) [70]

TP

Field evaluation

Rwanda

PMTCT clinics or VCT centres (3 urban community-level health centres)

PMTCT or VCT clinic attendees

Smartphone dongle with a triplexed immunoassay (HIV antibody, treponemal and non-treponemal antibodies for syphilis)

Fingerprick blood

Standalone project. No discussion of treatment

97% of patients preferred the dongle compared to laboratory-based tests

HCWs reported good feasibility

Fehler & Ballard (1998) [71]

TP

Cross-sectional pilot

South Africa

STD clinic (urban) & PHC clinic providing ANC (informal settlement)

Pregnant women & symptomatic STI clinic attendees

RPR

Venous blood

Integrated into routine care

Feasible

Before on-site screening: 73% (29/40) of reactive RPR tests at STD clinic and 50% (10/20) at ANC clinic treated for syphilis. Presumed that all those with positive RPR on-site received treatment although not explicitly stated

Withers et al. (2019) [72]

TP

Field evaluation

Vietnam

STI clinic (for MSM) and ANC

MSM and pregnant women

SD BIOLINE HIV/Syphilis Duo

Fingerprick blood

Standalone project. POCT results required confirmation

Flores et al. (2015) [73]

TP

Quasi-experimental time-series study

Peru

Reference hospital (peri-urban)

Hospital users seeking HIV/TP testing or pregnant women seeking ANC

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

52% clients completely satisfied and 48% satisfied with point-of-care testing

Baseline period: 61.0% of pregnant women tested for syphilis received timely results (within 45 min). Clients that did not receive their results within the 45-min norm, obtained their results after a minimum of 24 h, and often following days and weeks

Intervention period: 100% of pregnant women other key populations received timely results with POCTs

Marks et al. (2018) [74]

TP &

Yaws

Qualitative

Solomon Islands

Outpatient and ANC departments of a district hospital and four rural health clinics

HCWs and clinic patients

Chembio Dual Path Platform Syphilis Screen and Confirm test kit

Fingerprick blood

Integrated into routine care

Non-antenatal settings

Gupte et al. (2011) [75]

TP

Cross-sectional

India

Fixed, satellite and mobile clinics offering services for sex workers

Sex workers (female, male and transgender)

Qualpro Syphicheck-WB

Fingerprick blood

Standalone project. POCT results required confirmation

63.1% (19,809/31,395)

Introduction of rapid test improved feasibility of providing syphilis testing in all clinical settings, including mobile venues. Among the 19,809 SWs who accepted rapid syphilis testing, 598 tested positive (3.0% prevalence of lifetime syphilis infection). Among those screened with a positive rapid test, two-thirds accepted a confirmatory RPR test, with a reactivity rate of 85.3% (any titer) and 40.5% for active syphilis (RPR titer >/= 1:8)

Chen et al. (2012) [76]

TP

Cross-sectional

China

FSW outreach services at sex work venues

FSW

Wantai anti-TP Antibody Rapid Test

Fingerprick blood

Integrated into existing FSW outreach services—Clients referred to clinics for further diagnosis/treatment

95.0% (2670/2812)

Feasible to integrate into FSW outreach services

RDT results: 182/2670 (6.8%) had a positive result

136/182 (74.7%) of FSW with positive results were willing to attend a clinic for further confirmatory testing and treatment

Campos et al. (2006) [77]

TP

Field evaluation

Peru

Mobile outreach to commercial sex venues

FSW

Alere Determine syphilis TP

Fingerprick blood

Standalone project. POCT results determine treatment

97.4% (3586/3682)

0.3% invalid test rate. 87% POCT positives subsequently went onto get treatment and 64% completed the three-dose regimen. Relatively easy to use operationally and to incorporate into existing services

Parthasarathy et al. (2013) [78]

TP

Retrospective analysis

India

STI clinic

FSW, MSM, IVDU

Immunochromatographic strip test & RPR

Fingerprick blood

Integrated into STI programme

Avahan experience demonstrated that syphilis screening could be effectively integrated into a large-scale HIV prevention programme

The proportion of RDT used for screening increased from 7.4% in 2007 to 77.0% (p < 0.001) in 2009, replacing RPR as the predominant screening test. During the same period, the syphilis screening rates among clinic attendees increased from 9.0 to 21.6% (p < 0.001)

Mishra et al. (2010) [79]

TP

Field evaluation

India

STI clinic (fixed and mobile site camps)

FSW

Qualpro Syphicheck-WB

Fingerprick blood

Integrated into syphilis screening programme

POC overall:

33.4% (1627/4871)

POC, first-time attendees:

26.9% (1117/4157)

Standard protocol, first-time attendees:

18.9% (1017/5391)

Treatment completion: Off-site RPR = 44.8%. POC screening = 68.3% (p = 0.003)

POC—97.5% (115/118) of FSWs who tested positive received same-day treatment

This corresponding to at least one dose of treatment in 68.3% of women with active syphilis, as determined by the reference laboratory

Sabido et al. (2009) [80]

TP

Field evaluation

Brazil

STI clinic (urban)

STI clinic attendees including FSW, male clients of FSW, and other patients living or working in Manaus harbour area. HCWs and laboratory technicians

Omega Diagnostics VisiTect Syphilis

Fingerprick blood

Standalone project. POCT results determine treatment

52% of respondents stated that they would choose the conventional test over POCT

Operationally appropriate. Results of the time-flow analysis conducted among 84 patients showed that, excluding time spent receiving treatment for 7 (8.3%) patients, average time spent at the clinic was 51 min (SD 32)

Bristow et al. (2018) [81]

TP

Conjoint analysis

Peru

STI clinic (urban) and a gay men’s community health centre

MSM, TGW

Benzaken et al. (2008) [82]

TP

Field evaluation

Brazil

STI clinic (urban) & outreach clinic offering services near red-light district

STI clinic attendees including male and female sex workers and sex worker clients

Omega Diagnostics VisiTect Syphilis

Fingerprick blood

Standalone project. POCT results determine treatment

Reported as largely acceptable

Bien et al. (2015) [83]

TP

Qualitative

China

Urban community-based locations: (1) A local VCT site, (2) A local community-based organisation with ties to MSM community

MSM

Lipsitz et al. (2014) [84]

TP

Cross-sectional

Peru

Mobile testing unit (outreach)

MSM, TGW (although open to all visitors)

Inverness Medical Determine Rapid Syphilis TP

Fingerprick blood

Standalone project. POCT results required confirmation. (Positive results referred)

Allan-Blitz et al. (2019) [85]

TP

Cross-sectional

Peru

Outreach to MSM/TGW venues

MSM, TGW

SD BIOLINE HIV/Syphilis Duo

Fingerprick blood

Standalone project. POCT results required confirmation

303/585 (51.8%)

Pinto et al. (2014) [86]

TP

Cross-sectional

Brazil

Social support services (including shelters, hostels, homes and temporary charitable housings)

Homeless population with assisted social services

Omega Diagnostics VisiTect Syphilis

Fingerprick blood

Standalone project. POCT results determine treatment

86.6% (1405/2110)

All individuals with a positive RDT result agreed to start treatment right away, and, through the guidance of the multidisciplinary team, they were referred to health units to complete the treatment and for monitoring of the cure process

Hall et al. (2020) [87]

TP

Mixed methods

Macao, China

Community-based NGO study field site

Female Filipino migrant domestic workers

ABON Syphilis Ultra Rapid Test Device

Fingerprick blood

Standalone project. POCT results required confirmation (positive results referred)

85.3% (1164/1363)

Benzaken et al. (2007) [88]

TP

Field evaluation

Brazil

STI clinic (urban)

Patients self-presenting to a STI clinic

1. Qualpro Syphicheck-WB

2. SD Bioline Syphilis 3.0

3. Abbott Determine Rapid Syphilis TP

4. Omega Diagnostics VisiTect Syphilis

Venous blood

Standalone project. POCT results required confirmation

High reproducibility between clinic and lab teams (kappa > 0.9 across all test scenarios)

Gallo Vaulet et al. (2018) [89]

TP

Field evaluation

Argentina

STI clinic (urban)

Patients self-presenting to a STI clinic (50.2% MSM)

Alere Determine syphilis TP

Fingerprick blood

Integrated into routine care

31.1% (587/1887)

Ribeiro et al. (2015) [90]

TP

Cross-sectional

Brazil

Home

Residents in urban area of Amazonas state

SD Bioline Syphilis 3.0

Fingerprick blood

Standalone project. POCT results required confirmation

85.6% (1501/1752)

Eleven HCW evaluated four sample tubes for HIV and four DTS for syphilis. Of those, three (27.3%) interpreted at least one test result incorrectly for syphilis

Overall, 40/44 (90.9%) of the syphilis readings on dried test spots were correct

3 syphilis dried test spots (6.8%) were falsely reported as negatives

Nurses reported all the incorrect syphilis readings (as opposed to nurse practitioners)

Mark et al. (2017) [91]

TP

Observational cohort study

Kenya

Home

Male partners of pregnant women

SD Bioline Syphilis 3.0

Fingerprick blood

Standalone project. POCT results determine treatment

During partner’s pregnancy: 93% (74/80) 6 months post-partum: 98% (226/230)

Feasible and no effect on HIV testing

96% (151/158) accepted HIV testing prior to syphilis test introduction

95% (70/74) accepted HIV testing when both HIV and syphilis testing were offered

Ruffinen et al. (2015) [92]

TP

Implementation study

Brazil

PHC

HCWs involved in POC testing

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into routine care

HCWs reported that the acceptance of rapid testing was excellent or good at all ten polo bases

3 months after the introduction, 25.9% (6473/25,322) screened in Alto Solimões DSEI (11 polo bases)

Syphilis prevalence = 2.5% (165/6473)

86.7% of all syphilis-positive individuals started treatment following the rapid test and that all were referred for confirmatory testing. Failure to immediately treat syphilis-positive individuals was primarily caused by a lack of benzathine benzylpenicillin at four of the ten polo bases

Mashamba-Thompson et al. (2018) [93]

TP

Cross-sectional

South Africa

Rural PHC

PHC HCWs (operations managers, PHC specialist nurses, staff nurses)

Integrated into routine care

Only 0.5% of rural PHCs have currently accessible, available and in use syphilis tests

Smit et al. (2013) [94]

TP

Cross-sectional

Tanzania

Demographic surveillance study

Participants of community-based study (representative of population)

SD Bioline Syphilis 3.0

Fingerprick blood

Integrated into larger demographic surveillance study

West et al. (2002) [95]

TP

Cross-sectional

The Gambia

Rural community—field laboratory set up in 20 villages for a reproductive health survey

Women of reproductive age aged 15–54

RPR

Quorum Diagnostics RST

Venous blood

Standalone project. No discussion of treatment

97.7% (1295/1325) RPR tested in the field (field screening in these 30 women not carried out owing to logistical difficulties, either generator or equipment failure or lack of consumables in the field laboratory)

Parkes-Ratanshi et al. (2019) [96]

TP

E-mail survey

Uganda

Mixed public/private sector facilities

HCWs

Verwijs et al. (2019) [97]

CT

NG

TV

TP

Cross-sectional

Rwanda

Research clinic

Women aged 18 years or older at risk of acquiring STIs

Xpert CT/NG

OSOM Rapid Trichomonas Test

Alere Determine syphilis TP

Clinician-collected cervical swabs, Fingerprick blood

Standalone project. POCT results determine treatment. WISH algorithms used to determine who screened

100% (705/705) of enrolled participants accepted STI testing. 15.3% rejected HIV testing. 86.9% (344/396) chose to wait for the results. 100% clients who completed a satisfaction survey liked all testing procedures

Staff and participants considered point-of-care testing feasible and acceptable with tests easy to perform and interpret

Prevalences: CT = 8.5% (60/705). NG = 7·1% (50/705). TV = 16.1% (111/690)

WISH algorithms: CT sensitivity 71·7%, specificity 100%, NG sensitivity 76·0%, specificity 100%, and TV sensitivity 68·5%, specificity 97·4%

Garrett et al. (2018) [98]

CT

NG

TV

Prospective cohort pilot study

South Africa

Large urban public healthcare clinic

HIV negative women presenting for STI care

Xpert CT/NG

OSOM Rapid Trichomonas Test

Clinician-collected blind vaginal swabs

Standalone project. POCT results determine treatment

23.6% (63/267) were diagnosed with at least one of CT/NG/TV

Stime et al. (2018) [99]

CT

NG

TV

Mixed methods (time in motion study, qualitative)

South Africa

Large urban public healthcare clinic

STI clinic attendees

Xpert CT/NG

OSOM Rapid Trichomonas Test

Clinician-collected blind vaginal swabs

Standalone project. POCT results determine treatment

Syndromic management (n = 39): mean total visit duration = 2:05 and the mean clinical appointment duration was seven minutes

STI POCT (n = 9): mean total visit duration = 4:26. Mean additional visit time of 2:49 of which the longest step was running the GeneXpert samples (2:12). While the clinical visit accounted for 64% of the total time, much of this time was spent waiting for results

Staff in favour of expanding POCT

Badman et al. (2019) [100]

CT

NG

Diagnostic evaluation

Papua New Guinea

Survey (urban)

FSW, MSM, TGW

Xpert CT/NG

Self-collected anorectal swabs

Standalone project. POCT results determine treatment

99.95% (2134/2135)

98% (2095/2134) valid test results—144 (6.7%) invalid at first test, of which 105 (72.9%) generated a valid test on repeating testing

Jones et al. (2007) [101]

TV

RCT

South Africa

Home

Women aged 14–25

XenoStrip TV test#

Self-collected vaginal swabs

Standalone project. POCT results determine treatment

97% of women at the 6-week interview who successfully self-sampled reported that they would self-sample in the future

87% (146/168) test kits were received at the clinic from women who reported mailing them

96% contained the self-collected swab for PCR testing, 79% contained the used TV test strip, and 77% the self-administered questionnaire

Most women reported that self-sampling was easy or very easy, but more women in the clinic group reported this than women in the home group. 95% of these women reported being able to read the results, and 92% of the recorded results matched the reading by clinic staff. Almost all clinic women (98%) who came for their appointment were rated as finding it easy or very easy to perform the rapid test on their own. All women who tested positive were treated in both groups

Lippman et al. (2007) [102]

TV

RCT

Brazil

Home

Women aged 18–40 years recruited from the general clinic population and from the clinic catchment area

XenoStrip TV test

Self-collected vaginal swabs

Standalone project. POCT results required confirmation

96% (n = 787) were comfortable collecting their own vaginal sample and found self-collection easy

Overall, home-based testing was feasible: 94% of home group participants were able to complete collection and self-testing at home on their first attempt

80% of women in the home group returned samples to the study clinic within 2 weeks of enrolment compared with 76% of women presenting for screening in the clinic group (one-sided p = 0.06)

Following a reminder phone call or letter for non-responders at 2 weeks, a slightly higher proportion of home group participants responded before the 6-week follow-up visit (93%—381/410) as compared with clinic group response (89% (359/403) (one-sided p = 0.03)

Benzaken et al. (2006) [103]

NG

Field evaluation

Brazil

STI clinic (urban)

Women with vaginal discharge or referred by a partner with urethral discharge

NGThermo Biostar

Clinician-collected cervical swabs

Standalone project. No discussion of treatment

Three of the four staff members were able to obtain results within 30 min of receiving the specimen

Yin et al. (2006) [104]

CT

Field evaluation

China

STI clinics, female re-education centres and sex entertainment venues (urban)

Women at risk of chlamydia infection

Clearview Chlamydia MF

Clinician collected vaginal and cervical swabs

Standalone project. No discussion of treatment

Excellent agreements between the results read by two independent staff for either vaginal or cervical specimens in different study sites (k statistics 0.94–1.00 vaginal specimens and 0.96–1.00 for cervical specimens; all p values were < 0.001)

  1. ANC antenatal care; CT Chlamydia trachomatis; DRC Democratic Republic of the Congo; FSW female sex worker; HCW Healthcare worker; IVDU intravenous drug user; MSM men who have sex with men; NG Neisseria gonorrhoeae; NGO Non-governmental Organisation; PHC primary healthcare; POCT point-of-care test; RCT randomised controlled trial; RPR rapid plasma reagin; SD standard diagnostics (company); STI sexually transmitted infection; TGW transgender women; TV Trichomonas vaginalis; TP Treponema pallidum; VCT voluntary counselling and testing
  2. *Alere, formerly known as Inverness Medical Innovations, Inc, until 2010, acquired the Determine line of rapid tests from Abbott laboratories in 2005. Alere was subsequently acquired by Abbott in 2017
  3. #The Xenostrip TV test was acquired by Genzyme and sold under the brand OSOM. Sekisui acquired Genzyme’s diagnostics products business in 2011, and continues to sell the test as the OSOM Trichomonas rapid test