Reasons for late presentation for antenatal care, healthcare providers' perspective.

BACKGROUND: Antenatal care (ANC) provides healthcare services to pregnant women in an attempt to ensure, the best possible pregnancy outcome for women and their babies. Healthcare providers' understanding of their patient's behaviour and reasons for engagement in care and their response to this insight can influence patient-provider interactions and patient demand for ANC early in pregnancy. We examined the insight of healthcare providers into women's reasons for starting ANC later than the South African National Department of Health's recommended 20 weeks gestation. We also looked at the impact of late ANC presentation on overall healthcare providers' work experiences and their response in their interactions with patients. METHODS: In-depth interviews were conducted with 10 healthcare providers at Maternal Obstetrics Units (MOU) and Primary Healthcare Centres (PHC) in Gauteng, South Africa. Healthcare providers were selected with the assistance of the facility managers. Data analysis was conducted using the qualitative analysis software NVivo 11, using a thematic approach of pinpointing, examining, and recording patterns within the data. RESULTS: Healthcare providers were aware of patients need for secrecy in the early stages of pregnancy because of fears of miscarriage and women's preference for traditional care. Women with prior pregnancies presumed to know about stages of pregnancy and neglected to initiate ANC early. Barriers to early ANC initiation also include, women's need to balance income generating activities; travel cost to the clinic and refusal of care for coming after the daily patient limit has been reached. Healthcare providers encounter negative attitudes from un-booked patients. This has a reciprocal effect whereby this experience impacts on whether healthcare providers will react with empathy or frustration. CONCLUSIONS: Timing of ANC is influenced by the complex decisions women make during pregnancy, starting from accepting the pregnancy itself to acknowledging the need for ANC. To positively influence this decision making for the benefit of early ANC, barriers such as lack of knowledge should be addressed prior to pregnancy through awareness programmes. The relationship between healthcare providers and women should be emphasized when training healthcare providers and considered as an important factor that can affect the timing of ANC.

Predictors of switch to and early outcomes on third-line antiretroviral therapy at a large public-sector clinic in Johannesburg, South Africa.

BACKGROUND: While efficacy data exist, there are limited data on the outcomes of patients on third-line antiretroviral therapy (ART) in sub-Saharan Africa in actual practice. Being able to identify predictors of switch to third-line ART will be essential for planning for future need. We identify predictors of switch to third-line ART among patients with significant viraemia on a protease inhibitor (PI)-based second-line ART regimen. Additionally, we describe characteristics of all patients on third-line at a large public sector HIV clinic and present their early outcomes. METHODS: Retrospective analysis of adults (≥ 18 years) on a PI-based second-line ART regimen at Themba Lethu Clinic, Johannesburg, South Africa as of 01 August 2012, when third-line treatment became available in South Africa, with significant viraemia on second-line ART (defined as at least one viral load ≥ 1000 copies/mL on second-line ART after 01 August 2012) to identify predictors of switch to third-line (determined by genotype resistance testing). Third-line ART was defined as a regimen containing etravirine, raltegravir or ritonavir boosted darunavir, between August 2012 and January 2016. To assess predictors of switch to third-line ART we used Cox proportional hazards regression among those with significant viraemia on second-line ART after 01 August 2012. Then among all patients on third-line ART we describe viral load suppression, defined as a viral load < 400 copies/mL, after starting third-line ART. RESULTS: Among 719 patients in care and on second-line ART as of August 2012 (with at least one viral load ≥ 1000 copies/mL after 01 August 2012), 36 (5.0% over a median time of 54 months) switched to third-line. Time on second-line therapy (≥ 96 vs. < 96 weeks) (adjusted Hazard Ratio (aHR): 2.53 95% CI 1.03-6.22) and never reaching virologic suppression while on second-line ART (aHR: 3.37 95% CI 1.47-7.73) were identified as predictors of switch. In a separate cohort of patients on third-line ART, 78.3% (47/60) and 83.3% (35/42) of those in care and with a viral load suppressed their viral load at 6 and 12 months, respectively. CONCLUSIONS: Our results show that the need for third-line is low (5%), but that patients' who switch to third-line ART have good early treatment outcomes and are able to suppress their viral load. Adherence counselling and resistance testing should be prioritized for patients that are at risk of failure, in particular those who never suppress on second-line and those who have been on PI-based regimen for extended periods.

The right combination - treatment outcomes among HIV-positive patients initiating first-line fixed-dose antiretroviral therapy in a public sector HIV clinic in Johannesburg, South Africa.

BACKGROUND: Long-term antiretroviral therapy (ART) adherence is critical for achieving optimal HIV treatment outcomes. Fixed-dose combination (FDC) single-pill regimens, introduced in South Africa in April 2013, has simplified pill taking. We evaluated treatment outcomes among patients initiated on a FDC compared to a similar multi-pill ART regimen in Johannesburg, South Africa. METHODS: We conducted a retrospective cohort study of ART-naïve HIV-positive non-pregnant adult (≥18 years) patients without tuberculosis who initiated first-line ART on tenofovir and emtricitabine or lamivudine with efavirenz at Themba Lethu Clinic in Johannesburg, South Africa. We compared those initiated on a multi-pill ART regimen (3-5 pills/day; September 1, 2011-August 31, 2012) to those initiated on a FDC ART regimen (one pill/day; September 1, 2013-August 31, 2014). Treatment outcomes included attrition (combination of lost to follow-up and mortality), missed medical visits, and virologic suppression (viral load <400 copies/mL) by 12 months post-ART initiation. Cox proportional hazards models and Poisson regression were used to estimate the association between FDCs vs multiple pills and treatment outcomes. RESULTS: We included 3151 patients in our analysis; 2230 (70.8%) patients initiated multi-pill ART and 921 (29.2%) patients initiated on a FDC. By 12 months post-initiation, attrition (adjusted hazard ratio: 0.98; 95% CI: 0.77-1.24) was similar across regimen types (FDC vs multi-pill). Although not significant, patients on a FDC were marginally more likely to achieve viral suppression by 6 (adjusted relative rate [aRR]: 1.10; 95% CI: 0.99-1.23) and 12 months (aRR: 1.12; 95% CI: 0.92-1.36) on ART. Patients initiated on a FDC were significantly less likely to miss medical visits during the first 12 months of treatment (aRR: 0.66; 95% CI: 0.52-0.83). CONCLUSION: Our results suggest FDCs may have a role to play in supporting patient adherence and medical monitoring through improved medical visit attendance. This may potentially improve treatment outcomes later on in treatment.

Cohort profile: the Right to Care Clinical HIV Cohort, South Africa.

PURPOSE: The research objectives of the Right to Care Clinical HIV Cohort analyses are to: (1) monitor treatment outcomes (including death, loss to follow-up, viral suppression and CD4 count gain among others) for patients on antiretroviral therapy (ART); (2) evaluate the impact of changes in the national treatment guidelines around when to initiate ART on HIV treatment outcomes; (3) evaluate the impact of changes in the national treatment guidelines around what ART regimens to initiate on drug switches; (4) evaluate the cost and cost-effectiveness of HIV treatment delivery models; (5) evaluate the need for and outcomes on second-line and third-line ART; (6) evaluate the impact of comorbidity with non-communicable diseases on HIV treatment outcomes and (7) evaluate the impact of the switch to initiating all patients onto ART regardless of CD4 count. PARTICIPANTS: The Right to Care Clinical HIV Cohort is an open cohort of data from 10 clinics in two provinces within South Africa. All clinics include data from 2004 onwards. The cohort currently has data on over 115 000 patients initiated on HIV treatment and patients are followed up every 3-6 months for clinical and laboratory monitoring. FINDINGS TO DATE: Cohort data includes information on demographics, clinical visit, laboratory data, medication history and clinical diagnoses. The data have been used to identify rates and predictors of first-line failure, to identify predictors of mortality for patients on second-line (eg, low CD4 counts) and to show that adolescents and young adults are at increased risk of unsuppressed viral loads compared with adults. FUTURE PLANS: Future analyses will inform national models of HIV care and treatment to improve HIV care policy in South Africa.

Initiating antiretroviral therapy for HIV at a patient's first clinic visit: a cost-effectiveness analysis of the rapid initiation of treatment randomized controlled trial.

OBJECTIVE: Determine the cost and cost-effectiveness of single-visit (same-day) antiretroviral treatment (ART) initiation compared to standard of care initiation. DESIGN: Cost-effectiveness analysis of individually randomized (1 : 1) pragmatic trial of single-visit initiation, which increased viral suppression at 10 months by 26% [relative risk (95% confidence interval) 1.26 (1.05-1.50)]. SETTING: Primary health clinic in Johannesburg, South Africa. STUDY PARTICIPANTS: HIV positive, adult, nonpregnant patients not yet on ART or known to be eligible who presented at the clinic 8 May 2013 to 29 August 2014. INTERVENTION: Same-day ART initiation using point-of-care laboratory instruments and accelerated clinic procedures to allow treatment-eligible patients to receive antiretroviral medications at the same visit as testing HIV positive or having an eligible CD4 cell count. Comparison was to standard of care ART initiation, which typically required three to five additional clinic visits. MAIN OUTCOME MEASURE(S): Average cost per patient enrolled and per patient achieving the primary outcome of initiated 90 days or less and suppressed 10 months or less, and production cost per patient achieving primary outcome (all costs per primary outcome patients). RESULTS: The average cost per patient enrolled, per patient achieving the primary outcome, and production cost were $319, $487, and $738 in the standard arm and $451, $505, and $707 in the rapid arm. CONCLUSION: Same-day treatment initiation was more effective than standard initiation, more expensive per patient enrolled, and less expensive to produce a patient achieving the primary outcome. Omitting point-of-care laboratory tests at initiation and focusing on high-volume clinics have the potential to reduce costs substantially and should be evaluated in routine settings.

Mobility and Clinic Switching Among Postpartum Women Considered Lost to HIV Care in South Africa.

OBJECTIVE: Retention in HIV care, particularly among postpartum women, is a challenge to national antiretroviral therapy programs. Retention estimates may be underestimated because of unreported transfers. We explored mobility and clinic switching among patients considered lost to follow-up (LTFU). DESIGN: Observational cohort study. METHODS: Of 788 women initiating antiretroviral therapy during pregnancy at 6 public clinics in Johannesburg, South Africa, 300 (38.1%) were LTFU (no visit ≥3 months). We manually searched for these women in the South African National Health Laboratory Services database to assess continuity of HIV care. We used geographic information system tools to map mobility to new facilities. RESULTS: Over one-third (37.6%) of women showed evidence of continued HIV care after LTFU. Of these, 67.0% continued care in the same province as the origin clinic. Compared with those who traveled outside of the province for care, these same-province "clinic shoppers" stayed out-of-care longer {median 373 days [interquartile range (IQR): 175-790] vs. 175.5 days (IQR: 74-371)} and had a lower CD4 cell count on re-entry [median 327 cells/µL (IQR: 196-576) vs. 493 cells/µL (IQR: 213-557). When considering all women with additional evidence of care as engaged in care, cohort LTFU dropped from 38.1% to 25.0%. CONCLUSIONS: We found evidence of continued care after LTFU and identified local and national clinic mobility among postpartum women. Laboratory records do not show all clinic visits and manual matching may have been under- or overestimated. A national health database linked to a unique identifier is necessary to improve reporting and patient care among highly mobile populations.

Insights into Adherence among a Cohort of Adolescents Aged 12-20 Years in South Africa: Reported Barriers to Antiretroviral Treatment.

Adolescents experience disproportionately high rates of poor ART outcomes compared to adults despite prolonged use of antiretroviral therapy in Southern African treatment programs, presenting a significant challenge to national attempts to meet the UNAIDS 90-90-90 targets for 2020. This cohort study among adolescents aged 12-20 years accessing ART care at two urban public-sector clinics in Johannesburg between September and November 2013 aimed to identify factors potentially associated with poor attendance at clinic visits. Patients were followed up through routine medical records to identify missed visits (failing to attend clinic within 30 days of scheduled visit date) up to 2 years after enrolment. We enrolled 126 adolescents on ART for a median of 6.3 years (IQR: 2.7-8.4). A total of 47 (38%) adolescents missed a scheduled visit within 24 months of enrolment. Older adolescents (18-20 years) were more likely to miss a visit compared to adolescents aged 12-14 years (risk ratio (RR) = 1.72; 95% CI: 1.00-2.95). Those who were identified to have difficulty in taking medication (RR = 1.57; 95% CI: 1.13-2.18) as a barrier to care were more likely to miss a visit compared to adolescents who did not. Awareness of treatment fatigue, challenges to taking ART, and caregiver difficulties is important when considering interventions to improve treatment outcomes among adolescents.

Correction: Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.

[This corrects the article DOI: 10.1371/journal.pmed.1002015.].

Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.

BACKGROUND: High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit. METHODS AND FINDINGS: RapIT (Rapid Initiation of Treatment) was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC) and a hospital-based HIV clinic. Adult (≥18 y old), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study ("rapid arm") received a point-of-care (POC) CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB) test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV) dispensing. Patients in the standard-initiation arm of the study ("standard arm") followed standard clinic procedures (three to five additional clinic visits over 2-4 wk prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml) within 10 mo of study enrollment. Secondary outcomes included initiation of ART ≤90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis was conducted comparing attrition from care after ART initiation between the groups among those who initiated within 90 d. Three hundred and seventy-seven patients were enrolled in the study between May 8, 2013 and August 29, 2014 (median CD4 count 210 cells/mm3). In the rapid arm, 119/187 patients (64%) initiated treatment and were virally suppressed at 10 mo, compared to 96/190 (51%) in the standard arm (relative risk [RR] 1.26 [1.05-1.50]). In the rapid arm 182/187 (97%) initiated ART ≤90 d, compared to 136/190 (72%) in the standard arm (RR 1.36, 95% confidence interval [CI], 1.24-1.49). Among 318 patients who did initiate ART within 90 d, the hazard of attrition within the first 10 mo did not differ between the treatment arms (hazard ratio [HR] 1.06; 95% CI 0.61-1.84). The study was limited by the small number of sites and small sample size, and the generalizability of the results to other settings and to non-research conditions is uncertain. CONCLUSIONS: Offering single-visit ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. This intervention should be considered for adoption in the public sector in Africa. TRIAL REGISTRATION: ClinicalTrials.gov NCT01710397, and South African National Clinical Trials Register DOH-27-0213-4177.