Diagnostic accuracy of cervical cancer screening and screening-triage strategies among women living with HIV-1 in Burkina Faso and South Africa: A cohort study.

BACKGROUND: Cervical cancer screening strategies using visual inspection or cytology may have suboptimal diagnostic accuracy for detection of precancer in women living with HIV (WLHIV). The optimal screen and screen-triage strategy, age to initiate, and frequency of screening for WLHIV remain unclear. This study evaluated the sensitivity, specificity, and positive predictive value of different cervical cancer strategies in WLHIV in Africa. METHODS AND FINDINGS: WLHIV aged 25-50 years attending HIV treatment centres in Burkina Faso (BF) and South Africa (SA) from 5 December 2011 to 30 October 2012 were enrolled in a prospective evaluation study of visual inspection using acetic acid (VIA) or visual inspection using Lugol's iodine (VILI), high-risk human papillomavirus DNA test (Hybrid Capture 2 [HC2] or careHPV), and cytology for histology-verified high-grade cervical intraepithelial neoplasia (CIN2+/CIN3+) at baseline and endline, a median 16 months later. Among 1,238 women (BF: 615; SA: 623), median age was 36 and 34 years (p < 0.001), 28.6% and 49.6% ever had prior cervical cancer screening (p < 0.001), and 69.9% and 64.2% were taking ART at enrolment (p = 0.045) in BF and SA, respectively. CIN2+ prevalence was 5.8% and 22.4% in BF and SA (p < 0.001), respectively. VIA had low sensitivity for CIN2+ (44.7%, 95% confidence interval [CI] 36.9%-52.7%) and CIN3+ (56.1%, 95% CI 43.3%-68.3%) in both countries, with specificity for ≤CIN1 of 78.7% (95% CI 76.0%-81.3%). HC2 had sensitivity of 88.8% (95% CI 82.9%-93.2%) for CIN2+ and 86.4% (95% CI 75.7%-93.6%) for CIN3+. Specificity for ≤CIN1 was 55.4% (95% CI 52.2%-58.6%), and screen positivity was 51.3%. Specificity was higher with a restricted genotype (HPV16/18/31/33/35/45/52/58) approach (73.5%, 95% CI 70.6%-76.2%), with lower screen positivity (33.7%), although there was lower sensitivity for CIN3+ (77.3%, 95% CI 65.3%-86.7%). In BF, HC2 was more sensitive for CIN2+/CIN3+ compared to VIA/VILI (relative sensitivity for CIN2+ = 1.72, 95% CI 1.28-2.32; CIN3+: 1.18, 95% CI 0.94-1.49). Triage of HC2-positive women with VIA/VILI reduced the number of colposcopy referrals, but with loss in sensitivity for CIN2+ (58.1%) but not for CIN3+ (84.6%). In SA, cytology high-grade squamous intraepithelial lesion or greater (HSIL+) had best combination of sensitivity (CIN2+: 70.1%, 95% CI 61.3%-77.9%; CIN3+: 80.8%, 95% CI 67.5%-90.4%) and specificity (81.6%, 95% CI 77.6%-85.1%). HC2 had similar sensitivity for CIN3+ (83.0%, 95% CI 70.2%-91.9%) but lower specificity compared to HSIL+ (42.7%, 95% CI 38.4%-47.1%; relative specificity = 0.57, 95% CI 0.52-0.63), resulting in almost twice as many referrals. Compared to HC2, triage of HC2-positive women with HSIL+ resulted in a 40% reduction in colposcopy referrals but was associated with some loss in sensitivity. CIN2+ incidence over a median 16 months was highest among VIA baseline screen-negative women (2.2%, 95% CI 1.3%-3.7%) and women who were baseline double-negative with HC2 and VIA (2.1%, 95% CI 1.3%-3.5%) and lowest among HC2 baseline screen-negative women (0.5%, 95% CI 0.1%-1.8%). Limitations of our study are that WLHIV included in the study may not reflect a contemporary cohort of WLHIV initiating ART in the universal ART era and that we did not evaluate HPV tests available in study settings today. CONCLUSIONS: In this cohort study among WLHIV in Africa, a human papillomavirus (HPV) test targeting 14 high-risk (HR) types had higher sensitivity to detect CIN2+ compared to visual inspection but had low specificity, although a restricted genotype approach targeting 8 HR types decreased the number of unnecessary colposcopy referrals. Cytology HSIL+ had optimal performance for CIN2+/CIN3+ detection in SA. Triage of HPV-positive women with HSIL+ maintained high specificity but with some loss in sensitivity compared to HC2 alone.

Participatory action research to identify a package of interventions to promote postpartum family planning in Burkina Faso and the Democratic Republic of Congo.

BACKGROUND: The YAM DAABO study ("your choice" in Mooré) takes place in Burkina Faso and the Democratic Republic of Congo. It has the objective to identify a package of postpartum family planning (PPFP) interventions to strengthen primary healthcare services and determine its effectiveness on contraceptive uptake during the first year postpartum. This article presents the process of identifying the PPFP interventions and its detailed contents. METHODS: Based on participatory action research principles, we adopted an inclusive process with two complementary approaches: a bottom-up formative approach and a circular reflective approach, both of which involved a wide range of stakeholders. For the bottom-up component, we worked in each country in three formative sites and used qualitative methods to identify barriers and catalysts to PPFP uptake. The results informed the package design which occurred during the circular reflective approach - a research workshop gathering service providers, members of both country research teams, and the WHO coordination team. RESULTS: As barriers and catalysts were found to be similar in both countries and with the view to scaling up our strategy to other comparable settings, we identified a common package of six low-cost, low-technology, and easily-scalable interventions that addressed the main service delivery obstacles related to PPFP: (1) refresher training of service providers, (2) regularly scheduled and strengthened supportive supervision of service providers, (3) enhanced availability of services 7 days a week, (4) a counseling tool, (5) appointment cards for women, and (6) invitation letters for partners. CONCLUSIONS: Our research strategy assumes that postpartum contraceptive uptake can be increased by supporting providers, enhancing the availability of services, and engaging women and their partners. The package does not promote any modern contraceptive method over another but prioritizes the importance of women's right to information and choice regarding postpartum fertility options. The effectiveness of the package will be studied in the experimental phase. If found to be effective, this intervention package may be relevant to and scalable in other parts of Burkina Faso and the DRC, and possibly other Sub-Saharan countries. TRIAL REGISTRATION: Retrospectively registered in the Pan African Clinical Trials Registry ( PACTR201609001784334 , 27 September 2016).

Costs and cost-effectiveness of cervical cancer screening strategies in women living with HIV in Burkina Faso: The HPV in Africa Research Partnership (HARP) study.

INTRODUCTION: This study estimated the costs and incremental cost per case detected of screening strategies for high-grade cervical intraepithelial neoplasia (CIN2+) in women living with HIV (WLHIV) attending HIV clinics in Burkina Faso. METHODS: The direct healthcare provider costs of screening tests (visual inspection with acetic acid (VIA), VIA combined visual inspection with Lugol's iodine (VIA/VILI), cytology and a rapid HPV DNA test (careHPV)) and confirmatory tests (colposcopy, directed biopsy and systematic four-quadrant (4Q) biopsy) were collected alongside the HPV in Africa Research Partnership (HARP) study. A model was developed for a hypothetical cohort of 1000 WLHIV using data on CIN2+ prevalence and the sensitivity of the screening tests. Costs are reported in USD (2019). RESULTS: The study enrolled 554 WLHIV with median age 36 years (inter-quartile range, 31-41) and CIN2+ prevalence of 5.8%. The average cost per screening test ranged from US$3.2 for VIA to US$24.8 for cytology. Compared to VIA alone, the incremental cost per CIN2+ case detected was US$48 for VIA/VILI and US$814 for careHPV. Despite higher costs, careHPV was more sensitive for CIN2+ cases detected compared to VIA/VILI (97% and 56%, respectively). The cost of colposcopy was US$6.6 per person while directed biopsy was US$33.0 and 4Q biopsy was US$48.0. CONCLUSION: Depending on the willingness to pay for the detection of a case of cervical cancer, decision makers in Burkina Faso can consider a variety of cervical cancer screening strategies for WLHIV. While careHPV is more costly, it has the potential to be cost-effective depending on the willingness to pay threshold. Future research should explore the lifetime costs and benefits of cervical cancer screening to enable comparisons with interventions for other diseases.

Post-partum family planning in Burkina Faso (Yam Daabo): a two group, multi-intervention, single-blinded, cluster-randomised controlled trial.

BACKGROUND: Post-partum family planning services can prevent maternal and child morbidity and mortality in low-resource settings. We assessed the effect of a family planning intervention package on modern contraceptive use at 12 months post partum in predominantly rural Burkina Faso. METHODS: Yam Daabo was a two group, multi-intervention, single-blinded, cluster randomised controlled trial. Primary health-care centres were randomly allocated to intervention or control clusters in a 1:1 ratio with only data analysts masked to the allocation assignment. Interventions comprised refresher training for the provider, a counselling tool, supportive supervision, availability of contraceptive services 7 days a week, client appointment cards, and invitation letters for partners. The primary outcome was modern contraceptive prevalence at 12 months, and secondary outcomes were modern contraceptive prevalence at 6 weeks and 6 months post partum. Analysis was by modified intention to treat. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334). FINDINGS: From July 27-Oct 17, 2016, eight clinics were randomised and 571 women were enrolled and allocated: 286 to four intervention clusters and 285 to four control clusters. Of these, 523 completed the 12-month study exit interview (260 in the intervention group, 263 in the control group) and 523 were included in the intention-to-treat analysis. At 12 months, modern contraceptive prevalence was 55% among women who received the package and 29% among those who received routine care in control clusters (adjusted prevalence ratio 1·79, 95% CI 1·30-2·47). Significant differences in modern contraceptive prevalence were also seen between intervention and control groups at 6 weeks (42% and 10%, respectively; adjusted prevalence ratio 3·88, 95% CI 1·46-10·35) and 6 months (59% and 24%, respectively; 2·31, 1·44-3·71). INTERPRETATION: A package of six low-technology interventions, aimed at strengthening existing primary health-care services and enhancing demand for these services, can effectively increase modern contraceptive use for up to a year post partum in rural settings in Burkina Faso and has the potential to be suitable in similar settings in this country and others. FUNDING: Government of France.

Assessment Of Maternity Staff Training And Knowledge Of Obstetric Care In Burkina Faso: A Repeated Cross-Sectional Study.

BACKGROUND AND AIM: The quality of maternity care in low-income countries has often been questioned. The objective of this study was to describe the trend of the percentage of staff trained on selected obstetric care topics and their level of knowledge of maternal care over a 5-year period in Burkina Faso. METHODS: We conducted a secondary analysis of data from two national emergency obstetric and newborn care (EmONC) needs assessments. Staff members' knowledge scores were determined at the facility level for 2010 and 2014 and were further categorized into low (less than 50%), medium (50 to 74%) or high (at least 75%) levels. We used McNemar's test with a 5% significance level to compare the distribution of the proportions in 2010 versus 2014. RESULTS: Out of 789 facilities surveyed in the 2014 assessment, 736 (93.3%) were eligible for this study. Most of them were primary healthcare centers (87.2%). Overall, 21.6% (n=197) of health workers in 2010 and 39% in 2014 were midwives. The proportions of staff who received training on focused antenatal care (FANC) and on how to perform active management of the third stage of labor (AMSTL) have increased by 15.8% and 14.7%, respectively. A significant proportion of facilities had health workers with a low level of knowledge of FANC (p<0.001), the parameters that indicate the start of labor (p<0.001), the monitoring of labor progress (p<0.001) and AMSTL (p<0.001). There was no significant change in staff knowledge in hospitals over the 5-year period. CONCLUSION: From 2010 to 2014, the proportion of staff trained in obstetric care has increased. Their level of knowledge also improved, except in hospitals. However, further efforts are needed to reach a high level of knowledge.

Cervical intraepithelial neoplasia (CIN) in African women living with HIV: role and effect of rigorous histopathological review by a panel of pathologists in the HARP study endpoint determination.

AIMS: To analyse the effect of the expert end-point committee (EPC) review on histological endpoint classification of cervical intraepithelial neoplasia (CIN). METHODS: A cohort of women living with HIV were recruited in Burkina Faso (BF) and South Africa (SA) and followed over 18 months. Four-quadrant cervical biopsies were obtained in women with abnormalities detected by at least one screening test. A central review by a panel of five pathologists was organised at baseline and at endline. RESULTS: At baseline the prevalence of high-grade CIN (CIN2+) was 5.1% (28/554) in BF and 23.3% (134/574) in SA by local diagnosis, and 5.8% (32/554) in BF and 22.5% (129/574) in SA by the EPC. At endline the prevalence of CIN2+ was 2.3% (11/483) in BF and 9.4% (47/501) in SA by local diagnosis, and 1.4% (7/483) in BF and 10.2% (51/501) in SA by EPC. The prevalence of borderline CIN1/2 cases was 2.8% (32/1128) and 0.8% (8/984) at baseline and endline. Overall agreement between local diagnosis and final diagnosis for distinguishing CIN2+ from ≤CIN1 was 91.2% (κ=0.82) and 88.9% (κ=0.71) for BF at baseline and endline, and 92.7% (κ=0.79) and 98.7% (κ=0.97) for SA at baseline and endline. Among the CIN1/2 cases, 12 (37.5%) were graded up to CIN2 and 20 (62.5%) were graded down to CIN1 at baseline, and 3 (37.5%) were graded up to CIN2 and 5 (62.5%) were graded down to CIN1 at endline. CONCLUSIONS: This study highlights the importance of a centralised rigorous re-reading with exchange of experiences among pathologists from different settings.

Birth spacing and informed family planning choices after childbirth in Burkina Faso and the Democratic Republic of Congo: Participatory action research to design and evaluate a decision-making tool for providers and their clients.

OBJECTIVES: Postpartum family planning (PPFP) is essential for maternal and newborn health but is often not systematically addressed before or after childbirth. This article describes the development and field-testing of a PPFP counseling tool to support providers and women. METHODS: Participatory action research involving women, men, providers, policymakers, researchers, and contraceptive experts from Burkina Faso and the Democratic Republic of Congo. RESULTS: The tool consists of an A4-size flipchart with illustrations on the client side and clinical information and counseling tips on the provider side, and can be used during visits of the antenatal-delivery-postnatal care continuum. Qualitative results suggest that the tool is easily understandable, user-friendly, relevant, and useful with regard to providing PPFP information to clients, and respectful of clients' rights and choices. It may have a positive influence on clients' attitudes towards PPFP and their decision to use contraception. CONCLUSIONS: The tool holds promise in guiding a systematic discussion on birth spacing options among providers and clients. Its impact on contraceptive uptake requires further research. PRACTICE IMPLICATIONS: If proven effective, the tool could be disseminated to Ministries of Health and local, regional, and global partners to strengthen national family planning and maternal and child health strategies in low-resource countries.