HIV status disclosure, facility-based delivery and postpartum retention of mothers in a prevention clinical trial in rural Nigeria.

Background: Within the context of a cluster randomized prevention of mother-to-child HIV transmission (PMTCT) trial, we evaluated the impact of disclosure on selected PMTCT continuum of care measures. Methods: In 12 rural matched-pair clinics randomly assigned to an intervention package versus standard-of-care, we enrolled 372 HIV-infected pregnant women from April 2013 to March 2014. This secondary analysis included 327 (87.9%) women with unknown HIV status or who were treatment naïve at presentation to antenatal care. We employed mixed effects logistic regression to estimate impact of disclosure on facility delivery and postpartum retention in HIV care at 6 and 12 weeks. Results: Fully 86.5% (283/327) of women disclosed their HIV status to their partner, more in the trial intervention arm (OR 3.17, 95% CI 1.39-7.23). Adjusting for intervention arm, maternal age, education and employment, women who disclosed were more likely to deliver at a health facility (OR 2.73, 95%CI 1.11-6.72). Participants who disclosed also had a trend towards being retained in care at 6 and 12 weeks' postpartum (OR 2.72, 95% CI 0.79-9.41 and 2.46, 95% CI 0.70-8.63, respectively). Conclusions: HIV status disclosure at 6 weeks' postpartum was positively associated with facility-based delivery, but not with early postpartum retention. Facilitating HIV status disclosure to partners can increase utilization of facility obstetric services.

Patient and Provider Satisfaction With a Comprehensive Strategy to Improve Prevention of Mother-to-Child HIV Transmission Services in Rural Nigeria.

BACKGROUND: High mother-to-child HIV transmission rates in Nigeria are coupled with a critical shortage of trained health personnel, dearth of infrastructure, and low levels of male involvement in HIV care. This study evaluated maternal and provider satisfaction with services for prevention of mother-to-child transmission within the context of an implementation science cluster-randomized trial that included task shifting to lower-cadre workers, male engagement, point-of-care CD4 cell counts, and integrated mother-infant care. METHODS: Patient and clinician satisfaction were measured at 6 control and 6 intervention sites using a 5-point Likert scale. Patient satisfaction was assessed at 6 weeks postpartum through a 22-item scale about the provider's ability to explain the health problem, time spent with the clinician, and motivation to follow prescribed treatment. Provider satisfaction was assessed through a 12-item scale about motivation, compensation, and training, with 4 additional questions about the impact of task shifting on job satisfaction to intervention arm providers. RESULTS: We measured satisfaction among 340 mothers (intervention n = 160; control n = 180) and 60 providers (intervention n = 36; control n = 24). Total patient satisfaction (maximum 5) was higher in the intervention than control arm [median (interquartile range) = 4.61 (4.22-4.79) vs. 3.84 (3.22-4.22), respectively; P < 0.001]. Provider satisfaction was generally high, and was similar between the intervention and the control arms [median (interquartile range) = 3.60 (3.37-3.91) vs. 3.50 (3.08-4.25), respectively; P = 0.69]. Provider satisfaction dropped when questions on newly acquired provider roles were included [3.47 (3.25-3.72)]. Patient and provider satisfaction were not associated with uptake of antiretroviral therapy or mother-infant retention at 6 and 12 weeks postpartum. CONCLUSIONS: Satisfaction was higher among patients at intervention sites, and provider satisfaction decreased when newly assigned roles were factored in. Task shifting should include training and supportive oversight to ensure comfort with assigned tasks.

Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial.

BACKGROUND: Antiretroviral therapy (ART) and retention in care are essential for the prevention of mother-to-child HIV transmission (PMTCT). We aimed to assess the effect of a family-focused, integrated PMTCT care package. METHODS: In this parallel, cluster-randomised controlled trial, we pair-matched 12 primary and secondary level health-care facilities located in rural north-central Nigeria. Clinic pairs were randomly assigned to intervention or standard of care (control) by computer-generated sequence. HIV-infected women (and their infants) presenting for antenatal care or delivery were included if they had unknown HIV status at presentation (there was no age limit for the study, but the youngest participant was 16 years old); history of antiretroviral prophylaxis or treatment, but not receiving these at presentation; or known HIV status but had never received treatment. Standard of care included health information, opt-out HIV testing, infant feeding counselling, referral for CD4 cell counts and treatment, home-based services, antiretroviral prophylaxis, and early infant diagnosis. The intervention package added task shifting, point-of-care CD4 testing, integrated mother and infant service provision, and male partner and community engagement. The primary outcomes were the proportion of eligible women who initiated ART and the proportion of women and their infants retained in care at 6 weeks and 12 weeks post partum (assessed by generalised linear mixed effects model with random effects for matched clinic pairs). The trial is registered with ClinicalTrials.gov, number NCT01805752. FINDINGS: Between April 1, 2013, and March 31, 2014, we enrolled 369 eligible women (172 intervention, 197 control), similar across groups for marital status, duration of HIV diagnosis, and distance to facility. Median CD4 count was 424 cells per µL (IQR 268-606) in the intervention group and 314 cells per µL (245-406) in the control group (p<0·0001). Of the 369 women included in the study, 363 (98%) had WHO clinical stage 1 disease, 364 (99%) had high functional status, and 353 (96%) delivered vaginally. Mothers in the intervention group were more likely to initiate ART (166 [97%] vs 77 [39%]; adjusted relative risk 3·3, 95% CI 1·4-7·8). Mother and infant pairs in the intervention group were more likely to be retained in care at 6 weeks (125 [83%] of 150 vs 15 [9%] of 170; adjusted relative risk 9·1, 5·2-15·9) and 12 weeks (112 [75%] of 150 vs 11 [7%] of 168 pairs; 10·3, 5·4-19·7) post partum. INTERPRETATION: This integrated, family-focused PMTCT service package improved maternal ART initiation and mother and infant retention in care. An effective approach to improve the quality of PMTCT service delivery will positively affect global goals for the elimination of mother-to-child HIV transmission. FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development and US National Institutes of Health.

Pregnant women with HIV in rural Nigeria have higher rates of antiretroviral treatment initiation, but similar loss to follow-up as non-pregnant women and men.

BACKGROUND: We examined antiretroviral therapy (ART) initiation and retention by sex and pregnancy status in rural Nigeria. METHODS: We studied HIV-infected ART-naïve patients aged ≥15 years entering care from June 2009 to September 2013. We calculated the probability of early ART initiation and cumulative incidence of loss to follow-up (LTFU) during the first year of ART, and examined the association between LTFU and sex/pregnancy using Cox regression. RESULTS: The cohort included 3813 ART-naïve HIV-infected adults (2594 women [68.0%], 273 [11.8%] of them pregnant). The proportion of pregnant clients initiating ART within 90 days of enrollment (78.0%, 213/273) was higher than among non-pregnant women (54.3%,1261/2321) or men (53.0%, 650/1219), both p<0.001. Pregnant women initiated ART sooner than non-pregnant women and men (median [IQR] days from enrollment to ART initiation for pregnant women=7 days [0-21] vs 14 days [7-49] for non-pregnant women and 14 days [7-42] for men; p<0.001). Cumulative incidence of LTFU during the first year post-ART initiation was high and did not differ by sex and pregnancy status. Persons who were unemployed, bedridden, had higher CD4+ counts, and/or in earlier WHO clinical stages were more likely to be LTFU. CONCLUSIONS: Pregnant women with HIV in rural Nigeria were more likely to initiate ART but were no more likely to be retained in care. Our findings underscore the importance of effective retention strategies across all patient groups, regardless of sex and pregnancy status.

Enrolment trends in a comprehensive HIV programme in rural north-central Nigeria: improved care indices, but declining quality of clinical data over time.

BACKGROUND: Vanderbilt University affiliate Friends in Global Health was funded in 2008 to support comprehensive HIV/AIDS services in north-central Nigeria. We summarise programme characteristics and trends in enrolment and quality of data collection in this rural, resource-limited environment. METHODS: We used routinely collected programme data in supported sites from June 1 2009 to September 30, 2013.Baseline characteristics were defined as those collected closest to a 90-day window period before and after enrolment. Summary characteristics were compared by site and enrolment year. RESULTS: We enrolled 3,960 HIV-infected patients into care (68% women), median age of 32 years [interquartile range (IQR): 27-40]. Most clients were married (79%) and unemployed (60%). At enrolment, median CD4+ cell count was 230 cells/µL (IQR: 114-390) and haemoglobin was 10.7 g/dL (IQR: 9.3-11.9). Advanced clinical disease [World Health Organization (WHO) clinical stage III/IV] at enrolment was documented in 29% of clients. Cumulative enrolment increased from 377 patients in 2009 to 3,960 patients by 2013.With each successive year, more clients were enrolled at earlier stages of disease; in 2009, 37% of patients were identified as WHO clinical stage I, while in 2013, 55% of patients were so classified. While documentation of clinical staging remained stable, the completeness of CD4+ cell count and haemoglobin data declined with time. CONCLUSION: Expanded testing in a comprehensive HIV programme in rural Nigeria brought persons to care at earlier stages of illness. Yet, as clinical services expanded, data collection quality declined. The paradox of successful scaling up HIV services but deteriorating quality of data underscores the importance of data management training and quality improvement efforts.

Correlates of suboptimal entry into early infant diagnosis in rural north central Nigeria.

BACKGROUND: Despite an estimated 59,000 incident pediatric HIV infections in 2012 in Nigeria, rates of early infant diagnosis (EID) of HIV service uptake remain low. We evaluated maternal factors independently associated with EID uptake in rural North Central Nigeria. METHODS: We performed a cohort study using HIV/AIDS program data of HIV-infected pregnant women enrolled into HIV care/treatment on or before December 31, 2012 (n = 712). We modeled the probability of initiation of EID using multivariable logistic regression. RESULTS: Three hundred fifty-seven HIV-infected pregnant women enrolled their infants in EID across the 4 study sites. Women who enrolled their infants in EID vs. those who did not were similar across age, occupation, referral source, and select laboratory variables. Clinic of enrollment and date of enrollment were strong predictors for EID entry (P < 0.001). Women enrolled more recently were less likely to have their infants undergo EID than those enrolled at the beginning of the project (January 2011 vs. January 2010, adjusted odds ratio = 0.35, 95% confidence interval: 0.22 to 0.56; January 2012 vs. January 2010, adjusted odds ratio = 0.30, 95% confidence interval: 0.14 to 0.61). Women who received care in the more urban setting of Umaru Yar Adua Hospital were more likely to have their infants enrolled in EID than those who received care in the other 3 clinics. CONCLUSIONS: HIV-infected women in our prevention of mother-to-child HIV transmission program were more likely to bring in their infants for EID if they were enrolled in a more urbanized clinic location, and if they presented during an earlier phase of the program. The need for more intensive family engagement and program quality improvement is apparent, especially in rural settings.

Risk factors for delayed initiation of combination antiretroviral therapy in rural north central Nigeria.

BACKGROUND: Timely initiation of combination antiretroviral therapy (ART) in eligible HIV-infected patients is associated with substantial reduction in mortality and morbidity. Nigeria has the second largest number of persons living with HIV/AIDS in the world. We examined patient characteristics, time to ART initiation, retention, and mortality at 5 rural facilities in Kwara and Niger states of Nigeria. METHODS: We analyzed program-level cohort data for HIV-infected ART-naive clients (≥15 years) enrolled from June 2009 to February 2011. We modeled the probability of ART initiation among clients meeting national ART eligibility criteria using logistic regression with splines. RESULTS: We enrolled 1948 ART-naive adults/adolescents into care, of whom, 1174 were ART eligible (62% female). Only 74% of the eligible patients (n = 869) initiated ART within 90 days after enrollment. The median CD4 count for eligible clients was 156 cells/µL (interquartile range: 81-257), with 67% in WHO stage III/IV disease. Adjusting for CD4 count, WHO stage, functional status, hemoglobin, body mass index, sex, age, education, marital status, employment, clinic of attendance, and month of enrollment, we found that immunosuppression [CD4 350 vs. 200, odds ratio (OR) = 2.10, 95% confidence interval (CI): 1.31 to 3.35], functional status [bedridden vs. working, OR = 4.17 (95% CI: 1.63 to 10.67)], clinic of attendance [Kuta Hospital vs. referent: OR = 5.70 (95% CI: 2.99 to 10.89)], and date of enrollment [December 2010 vs. June 2009: OR = 2.13 (95% CI: 1.19 to 3.81)] were associated with delayed ART initiation. CONCLUSIONS: Delayed initiation of ART was associated with higher CD4 counts, lower functional status, clinic of attendance, and later dates of enrollment among ART-eligible clients. Our findings provide targets for quality improvement efforts that may help reduce attrition and improve ART uptake in similar settings.

Optimizing PMTCT service delivery in rural North-Central Nigeria: protocol and design for a cluster randomized study.

Nigeria has more HIV-infected women who do not receive needed services for the prevention of mother-to-child transmission of HIV (PMTCT) than any other nation in the world. To meet the UNAIDS/WHO goal of eliminating mother-to-child HIV transmission by 2015, multiple interventions will be required to scale up PMTCT services, especially to lower-level, rural health facilities. To address this, we are conducting a cluster-randomized controlled study to evaluate the impact and cost-effectiveness of a novel, family-focused integrated package of PMTCT services. A systematic re-assignment of patient care responsibilities coupled with the adoption of point-of-care CD4 + cell count testing could facilitate the ability of lower-cadre health providers to manage PMTCT care, including the provision and scale-up of antiretroviral therapy (ART) to pregnant women in rural settings. Additionally, as influential community members, male partners could support their partners' uptake of and adherence to PMTCT care. We describe an innovative approach to scaling up PMTCT service provision that incorporates considerations of where and from whom women can access services (task-shifting), ease of obtaining a CD4 + cell count result (point-of-care testing), the degree of HIV service integration for HIV-infected women and their infants, and the level of family and community involvement (specifically male partner involvement). This systematic approach, if proven feasible and effective, could be scaled up in Nigeria and similar resource-limited settings as a means to accelerate progress toward eliminating mother-to-child transmission of HIV and help women with HIV infection take ART and live long, healthy lives (Trial registration: NCT01805752).

Demographic predictors of HIV serostatus among HIV counseling and testing clients in rural Nigeria.

Nnewi is a rural Nigerian town with a human immunodeficiency virus (HIV) counseling and testing center which tests about 120 clients/d. The objective of this study is to determine the factors predicting positive HIV status at Nnewi. Review of records was done with age, gender, marital status, and occupation as variables. Logistic regression analysis was used to identify factors linked to a positive HIV test. Overall HIV prevalence was 31.14%. Drivers and married clients had a high risk of being HIV+ (odds ratio [OR], 3.59; 95% confidence interval [CI], 2.17-5.96 and OR, 2.78; 95% CI, 2.42-3.19). Housewives were 2 times more likely to be positive (OR, 2.11; 95% CI, 1.35-3.29). After adjustment, females had 22% higher risk (OR, 1.22; 95% CI, 1.03-1.45) with the highest chance found in married females (OR, 6.70; 95% CI, 4.45-10.09). The study succeeded in panning out an unexpected risk group: married women. Drivers have been known to be a risk group. Preventive methods must be tailored to and acceptable by each risk group.