Comparative effectiveness of implementation strategies for Accelerating Cervical Cancer Elimination through the integration of Screen-and-treat Services (ACCESS study): protocol for a cluster randomized hybrid type III trial in Nigeria.

BACKGROUND: Despite the increased risk of cervical cancer (CC) among women living with HIV (WLHIV), CC screening and treatment (CCST) rates remain low in Africa. The integration of CCST services into established HIV programs in Africa can improve CC prevention and control. However, the paucity of evidence on effective implementation strategies (IS) has limited the success of integration in many countries. In this study, we seek to identify effective IS to enhance the integration of CCST services into existing HIV programs in Nigeria. METHODS: Our proposed study has formative and experimental activities across the four phases of the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework. Through an implementation mapping conducted with stakeholders in the exploration phase, we identified a core package of IS (Core) and an enhanced package of IS (Core+) mostly selected from the Expert Recommendations for Implementing Change. In the preparation phase, we refined and tailored the Core and Core+ IS with the implementation resource teams for local appropriateness. In the implementation phase, we will conduct a cluster-randomized hybrid type III trial to assess the comparative effectiveness of Core versus Core+. HIV comprehensive treatment sites (k = 12) will be matched by region and randomized to Core or Core+ in the ratio of 1:1 stratified by region. In the sustainment phase, we will assess the sustainment of CCST at each site. The study outcomes will be assessed using RE-AIM: reach (screening rate), adoption (uptake of IS by study sites), IS fidelity (degree to which the IS occurred according to protocol), clinical intervention fidelity (delivery of CC screening, onsite treatment, and referral according to protocol), clinical effectiveness (posttreatment screen negative), and sustainment (continued integrated CCST service delivery). Additionally, we will descriptively explore potential mechanisms, including organizational readiness, implementation climate, CCST self-efficacy, and implementation intentions. DISCUSSION: The assessment of IS to increase CCST rates is consistent with the global plan of eliminating CC as a public health threat by 2030. Our study will identify a set of evidence-based IS for low-income settings to integrate evidence-based CCST interventions into routine HIV care in order to improve the health and life expectancy of WLHIV. TRIAL REGISTRATION: Prospectively registered on November 7, 2023, at ClinicalTrials.gov no. NCT06128304. https://classic. CLINICALTRIALS: gov/ct2/show/study/NCT06128304.

Evaluating the hemostatic effects of tranexamic acid in women with pre-eclampsia.

OBJECTIVE: To evaluate the hemostatic effects of tranexamic acid (TXA) ex vivo in women with pre-eclampsia. METHODS: This was an ex vivo study involving 45 normal pregnant women and 45 women with pre-eclampsia (nine with mild and 36 with severe features) matched for age, gestational age, and body mass index. Blood samples were collected and divided into two parts. The first served as the pre-TXA sample, while the second was spiked with TXA and served as the post-TXA sample. Plasma levels of D-dimer and plasmin-antiplasmin complex (PAP) were determined using enzyme-linked immunosorbent assay. RESULTS: The mean D-dimer and PAP values in the pre-TXA samples differed significantly between groups. Following spiking with TXA, the mean D-dimer and PAP levels did not differ significantly in the pre-TXA and post-TXA samples (P = 0.560 and P = 0.500, respectively) in the pre-eclampsia cohort. In normal pregnancy, the mean D-dimer and PAP levels in the post-TXA samples did not differ significantly (P = 0.070 and P = 0.050, respectively) from the pre-TXA samples following TXA spiking. CONCLUSION: TXA did not significantly affect D-dimer and PAP levels in pre-eclampsia, suggesting that TXA may not increase the thrombotic risks in patients with pre-eclampsia.

Thermo-coagulation versus cryotherapy for treatment of cervical precancers: A prospective analytical study in a low-resource African setting.

AIMS: To evaluate the outcomes of cryotherapy and thermo-coagulation in the treatment of cervical precancers. METHOD: Prospective analytical study. Women who screened positive to visual inspection with acetic acid and confirmed by colposcopy using the Swede's score were randomized to receive either cryotherapy or thermo-coagulation. Participants were re-evaluated 6 months later. RESULTS: A total of 11 124 women were screened. Only 1023 of the 1294 colposcopically confirmed positive cases were eligible for ablative therapy. Five hundred and twelve women received cryotherapy while 511 women received thermo-coagulation. Cryotherapy had similar cure rate with thermo-coagulation (85.5 vs 89.2%, P = 0.09). The mean patient satisfaction score for thermo-coagulation was higher than that for cryotherapy (3.9 ± 1.3 vs 2.8 ± 1.7; P < 0.0001). The mean duration of treatment per patient was higher for cryotherapy than thermo-coagulation (660.0 ± 0.0 vs 50.9 ± 15.3 s, P < 0.0001). The mean cost of treatment per patient was significantly higher for cryotherapy than for thermo-coagulation (2613.1 ± 254.9 vs 533.2 ± 45.2 Nigerian Naira, P < 0.0001). Higher proportion of women who had thermo-coagulation reported no side effect (55.2 vs 12.5%, P < 0.0001). CONCLUSION: Cryotherapy and thermo-coagulation have similar efficacy in the treatment of cervical precancers. Thermo-coagulation offers lower cost and lower duration of treatment, less side effects and higher patient satisfaction than cryotherapy. Thermo-coagulation should be the recommended ablative treatment method for low-resource settings of the world.

The impact of community health educators on uptake of cervical and breast cancer prevention services in Nigeria.

OBJECTIVE: To determine the impact of trained community health educators on the uptake of cervical and breast cancer screening, and HPV vaccination in rural communities in southeast Nigeria. METHODS: A prospective population-based intervention study, with a before-and-after design, involved four randomly selected communities in southeast Nigeria from February 2014 to February 2016. Before the intervention, baseline data were collected on the uptake of cervical and breast cancer prevention services. The intervention was house-to-house education on cervical cancer and breast cancer prevention. Postintervention outcome measures included the uptake of cervical and breast cancer screening, and HPV vaccination within 6 months of intervention. RESULTS: In total, 1327 women were enrolled. Before the intervention, 42 (3.2%) women had undergone cervical cancer screening; afterwards, 897 (67.6%) women had received screening (P<0.001). Clinical breast examination was performed for 59 (4.4%) women before and 897 (67.6%) after the intervention (P<0.001). Only 2 (0.9%) of 214 children eligible for HPV vaccination had received the vaccine before versus 71 (33.2%) after the intervention (P<0.001). CONCLUSION: The use of community health educators for house-to-house cervical and breast cancer prevention education was associated with significant increases in the uptake of cervical cancer screening, clinical breast examination, and HPV vaccination.

Prevalence and pattern of rape among girls and women attending Enugu State University Teaching Hospital, southeast Nigeria.

OBJECTIVE: To determine the prevalence and pattern of rape in Enugu, southeast Nigeria. METHODS: A prospective descriptive study was conducted among female survivors of rape who presented at the emergency gynecologic and/or forensic unit of Enugu State University Teaching Hospital between February 2012 and July 2013. Data were collected via a pretested interviewer-administered questionnaire. RESULTS: Among 1374 gynecologic emergencies, there were 121 (8.8%) rape cases. The mean age of the rape survivors was 13.1±8.1 years. Ninety (74.4%) survivors were younger than 18 years. At least 72 hours had passed since the rape for 74 (61.2%) cases. The perpetrator was known to 74 (82.2%) patients younger than 18 years and 18 (58.1%) aged at least 18 years (P=0.013). The location of the rape was the bush or an uncompleted building for 36 (29.8%) and the perpetrator's residence for another 36 (29.8%). Four (3.3%) individuals became pregnant after the rape. CONCLUSION: A considerable proportion of patients with gynecologic emergencies had been raped. Individuals should be encouraged to report to the hospital quickly to prevent unwanted pregnancy and sexually transmitted infections.

Experiences and unmet needs of women undergoing Pap smear cervical cancer screening: impact on uptake of cervical cancer screening in south eastern Nigeria.

The burden of cervical cancer is on the increase in sub-Saharan Africa mainly due to inadequate provision and utilisation of cervical cancer prevention services. Several evidence-based strategies have been deployed to improve cervical cancer screening uptake without much success. However, patients' experiences and satisfaction with service provision has not been adequately studied. Inefficiencies in service delivery and less fulfilling experiences by women who attend cervical cancer screening could have considerable impact in future voluntary uptake of cervical cancer screening. Six hundred and eighty women who underwent Pap smear screening in three health care facilities in two states in south eastern Nigeria were interviewed to evaluate their satisfaction, willingness to undertake future voluntary screening, unmet needs and correlation between satisfaction level and willingness to undergo future screening. Satisfaction with Pap smear screening correlated positively with willingness to undertake future voluntary screening (Pearson's correlation coefficient = 0.78, P = 0.001). The mean satisfaction score was significantly higher among participants handled by nurses than those handled by the physicians (3.16 ± 0.94 vs 2.52 ± 0.77, P = 0.001). 'Scrapping discomfort' of the spatula was reported as the most dissatisfying aspect of Pap smear experience. The need for less invasive screening procedures was the most unmet need. It was concluded that improving the Pap smear screening experience of women and providing less invasive methods of cervical cancer screening with immediate results could improve uptake of cervical cancer screening in south eastern Nigeria.

Use of a portable diathermy machine for LEEP without colposcopy during see-and-treat management of VIA-positive cervical lesions in resource-poor settings.

OBJECTIVE: To compare the effectiveness of cryotherapy and loop electrosurgical excision procedure without colposcopy (visual LEEP) in treating cervical lesions detected through visual inspection with acetic acid (VIA). METHODS: In rural southeast Nigeria, women with VIA-positive lesions who were eligible for ablative treatment were selected to undergo immediate cryotherapy with nitrous oxide. Women with VIA-positive lesions who were not eligible for ablative treatment were selected to undergo visual LEEP at the same visit. A portable diathermy machine was used for LEEP. Participants were re-evaluated 6 months later using VIA. The main outcome measures included persistent VIA positivity at 6 months, duration of procedure, second clinic visits for complications, and patient acceptability. RESULTS: In total, 304 women completed the study. Persistent VIA-positivity rates, duration of procedure, second clinic visits for complications, and patient acceptability were similar in the 2 groups. CONCLUSION: Visual LEEP and cryotherapy have similar efficacy and patient acceptability in see-and-treat management of VIA-positive cervical lesions. In see-and-treat VIA-based cervical cancer prevention programs in low-resource countries, visual LEEP can be used to treat women who do not meet the criteria for ablative treatment. This would increase the treatment coverage of women with VIA-positive lesions and improve program efficiency.

See-and-treat management of high-grade squamous intraepithelial lesions in a resource-constrained African setting.

OBJECTIVE: To compare the treatment outcomes of women with high-grade squamous intraepithelial lesions (HSIL) who underwent immediate loop electrosurgical excision procedure (LEEP) and those who had directed biopsies prior to subsequent LEEP. METHODS: Women who were referred for HSIL to 2 centers in southeast Nigeria were examined via colposcopy. Those with positive colposcopic findings were randomized to receive either immediate LEEP (see-and-treat group) or directed biopsies (3-step group). Women with directed biopsy-confirmed results underwent follow-up LEEP. Overtreatment rate, cost, default rate, and cytology-treatment interval were compared between the 2 groups. RESULTS: In total, 314 women were included in the study. The overtreatment rate was similar between the groups. Treatment cost and cytology-treatment interval were significantly higher in the 3-step group (P=0.0001). The default rate was significantly lower in the see-and-treat group (P=0.0001). Most (219 [69.7%]) participants preferred the see-and-treat approach. CONCLUSION: Immediate see-and-treat LEEP for women with HSIL in southeast Nigeria is cheaper, less time-consuming, and associated with better patient compliance than the 3-step management procedure. Furthermore, it does not lead to significantly higher overtreatment. The immediate see-and-treat approach may be ideal for the management of women with HSIL in low-resource countries.

Denial of women's rights to contraception in southeastern Nigeria.

OBJECTIVE: To evaluate the opinions and experiences of married women in southeastern Nigeria regarding their rights to contraception, in addition to the impact of the denial of women's contraceptive rights on unplanned pregnancy rate. METHODS: A cross-sectional survey of women who registered for prenatal care at 2 federal tertiary healthcare facilities in southeastern Nigeria was conducted. Randomly selected samples of participants were interviewed via a structured, pretested questionnaire. RESULTS: In total, 1204 women participated in the survey. Overall, 526 (43.7%) were unaware of their rights to contraception. Denial of contraceptive rights was reported by 522 (43.4%) women. In total, 174/317 (54.9%) women with unplanned pregnancies blamed denial of access to contraception for their pregnancies. Among the women who had used contraception previously, 61.9% reported that the decision to do so was taken by their spouse. Formal education seemed to increase women's level of awareness of their rights to contraception (P=0.001) but it did not influence the exercising of such rights. CONCLUSION: A considerable proportion of women in southeastern Nigeria are being denied their rights to contraception, mainly owing to a culture of male dominance. There may be significant health implications for women with unplanned pregnancies arising from such denials.

Motivations and preferences of rural Nigerian women undergoing cervical cancer screening via visual inspection with acetic acid.

OBJECTIVE: To determine the motivations and preferences of women participating in visual inspection with acetic acid (VIA) mass cervical cancer screening programs in southeastern Nigeria. METHODS: By means of interviewer-based questionnaires, data were collected from women participating in mass cervical cancer screenings with VIA in 3 randomly selected communities in each of 2 southeastern Nigerian states between March 1, 2011, and March 31, 2012. RESULTS: A total of 2312 women were interviewed. Support from husband and community opinion leaders were the most frequently reported factors that motivated the women to participate in the screening. Most participants expected an immediate result for the screening test and immediate treatment for any abnormalities detected. CONCLUSION: Community-based advocacy for cervical cancer screening is a very effective method of creating awareness for cervical cancer screening. Support from spouses and community leaders are important factors in a woman's decision to utilize cervical cancer screening services in southeastern Nigeria. Immediate results and treatments would make the most impact. Family and community participation should be integrated into cervical cancer prevention programs. This, together with a "see and treat" approach, may be central to overcoming the poor utilization of cervical cancer screening services in Nigeria and similar rural settings.

The perception and use of chaperones by Nigerian gynecologists.

OBJECTIVE: To determine how Nigerian gynecologists perceive and use chaperones during intimate gynecologic examinations. METHODS: A cross-sectional survey of Nigerian gynecologists was conducted with the aid of self-administered, semi-structured questionnaires. Data were analyzed for descriptive and inferential statistics. RESULTS: In all, 97.6% of respondents considered the use of a chaperone necessary during intimate gynecologic examinations and recommended that the Society of Gynaecology and Obstetrics of Nigeria (SOGON) should endorse the routine offer of chaperones for such examinations. However, just 35.9% of male physicians always or often used chaperones, while 76.9% of female physicians used chaperones only under special circumstances. No female physician always or often used a chaperone during pelvic examination. The main obstacles to the use of chaperones were scarcity of personnel to serve in this capacity (87.6%) and patients' refusal to be examined in the presence of a third party (12.4%). CONCLUSION: Most Nigerian gynecologists use chaperones at least some of the time and also support a policy of routinely offering chaperones during intimate gynecologic examination while respecting patients' right to decline this offer. Scarcity of personnel to serve as chaperones is the greatest challenge to the implementation of this policy.

Experiences of women undergoing colposcopy in southeastern Nigeria.

OBJECTIVE: To evaluate the experiences, preferences, and needs of women undergoing colposcopy in southeastern Nigeria. METHODS: Women undergoing colposcopy at 2 centers in southeastern Nigeria between August 1, 2009, and October 31, 2011, were interviewed using structured interviewer-administered questionnaires. RESULTS: In total, 409 women were interviewed. The majority (60.8%) of these women were satisfied with the overall process of colposcopy. Invasion of privacy and re-assuring attitude of attending clinic personnel were reported as the most dissatisfying and most satisfying aspects of colposcopy, respectively. Privacy during the procedure and written take-home information were the most frequently reported needs. Most participants preferred a female colposcopist and the presence of their spouse during colposcopic examination. CONCLUSION: Southeastern Nigerian women are less satisfied with the overall process of colposcopy than their counterparts from high-income settings. The majority of the women interviewed would have an improved colposcopic experience if their privacy concerns and information needs were addressed and their spouses allowed into the examination room. The findings from the present study should encourage existing and emerging colposcopy service providers in low-resource settings to improve both service delivery and their patients' overall colposcopic experience.

Denial of pain relief during labor to parturients in southeast Nigeria.

OBJECTIVE: To evaluate the experiences of parturients with regard to pain relief during labor in Enugu, Nigeria. METHODS: Women attending the prenatal clinics of 3 maternity care centers were interviewed via pre-tested interviewer-administered questionnaires between August 2010 and January 2011. Both open and closed questions were asked to evaluate the opinions and experiences of the respondents with regard to labor analgesia in previous pregnancies. RESULTS: Overall, 34.1% of respondents were aware of their right to labor pain relief. Only 33.5% of maternal requests for labor pain relief were granted. Women who did not request labor analgesia indicated ignorance and fear of labor caregivers as their major reasons. CONCLUSION: Most women in southeast Nigeria are unaware of their right to pain relief in labor. Ignorance and fear of unfavorable reactions from labor caregivers are hindering women from requesting labor analgesia. There is a need to address the issue of refusal of maternal requests for labor pain relief because it constitutes a violation of the fundamental right of the parturient and an unnecessary breach of medical ethics.

Non-uptake of colposcopy in a resource-poor setting.

OBJECTIVE: To determine the rate of acceptance/refusal of colposcopy and the reasons for refusal by women referred for the procedure in southeast Nigeria. METHODS: An audit was performed of the computerized database for all women referred for colposcopy at the University of Nigeria Teaching Hospital, Enugu, from August 1, 2009, to July 31, 2010. The characteristics of those who accepted colposcopy were compared with those who refused the procedure. An interviewer-administered questionnaire was used to assess reasons for refusal and the subsequent treatment chosen. RESULTS: During the study period, 154 women were referred for colposcopy: 103 (66.9%) accepted and 51 (33.1%) refused. Those who refused were younger and tended to be nulliparous (P=0.029 and P=0.004, respectively). The most common reasons for refusal were fears of possible diagnosis of cervical cancer and compromise of future fertility. Most women who refused resorted to spiritual healing. CONCLUSION: The rate of refusal of colposcopy in southeast Nigeria was high, indicating an urgent need for appropriate remedial measures instituted through intensive education of women regarding cervical cancer and its prevention. Targeted counseling should be initiated early as part of prescreening counseling.

Sexual violations among married women in southeastern Nigeria.

OBJECTIVE: To investigate domestic sexual violations in southeastern Nigeria and the opinions of married women regarding sexual rights for women. METHOD: Married women attending gynecologic clinics at 3 major hospitals in Enugu, Nigeria, completed a structured questionnaire. RESULTS: A culture of male dominance seemed to be the leading cause for the following high rates: husband's total monopoly on decisions regarding sex, 54.1%; inability to refuse the husband's demands for sex, 60.7%; sex-related verbal abuse, 39.3%; sex-related physical violence, 16.2%; and forced sex, 19.1%. Women with a university education and unemployed women reported sexual violations more frequently than did others. Most respondents supported sexual rights for women. CONCLUSION: Married women in southeastern Nigeria still are denied sexual rights, apparently owing to a culture of male dominance. A higher education alone may not lead to the advent of sexual rights for women, and a greater emphasis should be placed on societal reorientation.

Obstetricians' opinions and attitudes toward maternal refusal of recommended cesarean delivery in Nigeria.

OBJECTIVE: To assess the opinions and attitudes of Nigerian obstetricians toward women's refusal of cesarean delivery. METHOD: We used a questionnaire with 5 clinical scenarios drawn from published cases in which Nigerian women refused to undergo a recommended cesarean delivery. RESULTS: Most obstetricians (84.8%) advocated continuous counseling of these women but, from their response to the scenarios, few (13.7%-16.1%) would actually do so. Insufficient facilities and poor logistics for emergency obstetric care were their stated major reason for not respecting maternal choices in situations where vaginal delivery could have been given a chance. CONCLUSION: The possibility of providing emergency obstetric care would remove many indications for cesarean delivery from the list of absolute indications in Nigeria; and management guidelines would protect obstetricians in the event of litigation, and improve their acceptance and respect of maternal choice.

Intrapartum stillbirth in a Nigerian tertiary hospital setting.

OBJECTIVE: To examine the nonmedical events contributing to intrapartum stillbirths in an African setting. METHODS: Retrospective analysis of the records of women who had intrapartum stillbirths at the University of Nigeria Teaching Hospital, Enugu, from January 1999 to December 2007. The events surrounding the delivery of these women were critically analyzed and statistically compared with those who had live births to determine the nonmedical factors contributing to the stillbirths. RESULTS: The overall stillbirth rate was 89 per 1000 births. The intrapartum stillbirth rate was 52.1 per 1000 births. Nonmedical factors contributing to stillbirths included delays in receiving appropriate management, inadequate intrapartum monitoring, inappropriate interventions, and wrong diagnosis. All 3 types of delay were significantly associated with intrapartum stillbirth (P=0.0001). CONCLUSION: Intrapartum stillbirth accounts for the majority of stillbirths in this setting. Avoidable delays, suboptimal intrapartum monitoring, and inappropriate interventions contribute to the majority of intrapartum stillbirths in Nigeria.