Contraceptive use and pregnancy rates among women receiving antiretroviral therapy in Malawi: a retrospective cohort study

Abstract Background In 2011, family planning (FP) services were integrated at Martin Preuss Centre (MPC), in urban Lilongwe, Malawi. To date, no previous study evaluated pregnancy rates among HIV-positive women after the integration of FP services into HIV care at the facility. In this study, we investigated whether integration of FP services into HIV clinical care led to increased use of contraceptives and decreased pregnancy rates. Methods This was a retrospective cohort analysis of HIV-positive women from 15 to 49 years of age who accessed antiretroviral therapy (ART) services at MPC. Ascertainment of FP needs, contraceptive methods and pregnancy status were done at ART initiation, and at each ART follow-up visit. Women were offered a wide range of contraceptive methods. Outcomes of interest were contraceptive use and rate of pregnancy. Incident pregnancy was ascertained through patient self-reports during clinic consultation. Trends of contraceptive use and pregnancy rates were analyzed using chi-square (χ2). Results A total of 10,472 women were included in the analysis and contributed 15,700 person-years of observation. Contraceptive use among all women receiving ART increased from 28% in 2012 to 62% in 2016 (p < 0.001). A total of 501 pregnancies occurred, including 13 multiple pregnancies, resulting in an overall pregnancy rates of 3.2 per 100 person-years. Rates of pregnancy decreased from 6.8 per 100 person-years in 2012 to 1.3 per 100 person-years in 2016 (p < 0.001). Conclusion Integration of FP services into HIV care resulted in increased contraceptive use and, subsequently, decreased pregnancy rates in women receiving ART. HIV programs should consider offering FP services to women who are receiving ART

Follow-up and programmatic outcomes of HIV-exposed infants registered in a large HIV centre in Lilongwe, Malawi: 2012-2014.

OBJECTIVE: To assess follow-up and programmatic outcomes of HIV-exposed infants at Martin Preuss Centre, Lilongwe, from 2012 to 2014. METHODS: Retrospective cohort study using routinely collected HIV-exposed infant data. Data were analysed using frequencies and percentages in Stata v.13. RESULTS: Of 1035 HIV-exposed infants registered 2012-2014, 79% were available to be tested for HIV and 76% were HIV-tested either with DNA-PCR or rapid HIV test serology by 24 months of age. Sixty-five infants were found to be HIV-positive and 43% were started on antiretroviral therapy (ART) at different ages from 6 weeks to 24 months. Overall, 48% of HIV-exposed infants were declared lost-to-follow-up in the database. Of these, 69% were listed for tracing; of these, 78% were confirmed as lost-to-follow-up through patient charts; of these, 51% were traced; and of these, 62% were truly not in care, the remainder being wrongly classified. Commonest reasons for being truly not in care were mother/guardian unavailability to bring infants to Martin Preuss Centre, forgetting clinic appointments and transport expenses. Of these 86 patients, 36% were successfully brought back to care and 64% remained lost-to-follow-up. CONCLUSION: Loss to follow-up remains a huge challenge in the care of HIV-exposed infants. Active tracing facilitates the return of some of these infants to care. However, programmatic data documentation must be urgently improved to better follow-up and link HIV-positive children to ART

Loss to follow-up before and after initiation of antiretroviral therapy in HIV facilities in Lilongwe, Malawi

Although several studies have explored factors associated with loss to follow-up (LTFU) from HIV care, there remains a gap in understanding how these factors vary by setting, volume of patient and patients’ demographic and clinical characteristics. We determined rates and factors associated with LTFU in HIV care Lilongwe, Malawi

A cross-sectional study to evaluate second line virological failure and elevated bilirubin as a surrogate for adherence to atazanavir/ritonavir in two urban HIV clinics in Lilongwe, Malawi

BACKGROUND: Malawi's national antiretroviral therapy program provides atazanavir/ritonavir-based second line regimens which cause concentration-dependent rise in indirect bilirubin. We sought to determine if elevated bilirubin, as a surrogate of atazanavir/ritonavir adherence, can aid in the evaluation of second line virological failure in Malawi. METHODS: We conducted a cross-sectional study of HIV-infected patients ≥15 years who were on boosted protease inhibitor-based second line antiretroviral therapy for at least 6 months in two urban HIV clinics in Lilongwe, Malawi. Antiretroviral therapy history and adherence data were extracted from the electronic medical records and blood was drawn for viral load, complete blood count, total bilirubin, and CD4 cell count at a clinic visit. Factors associated with virological failure were assessed using multivariate logistic regression model. RESULTS: Out of 376 patients on second line antiretroviral therapy evaluated, 372 (98.9%) were on atazanavir/ritonavir-based therapy and 142 (37.8%) were male. Mean age was 40.9 years (SD ± 10.1), mean duration on second line antiretroviral therapy was 41.9 months (SD ± 27.6) and 256 patients (68.1%) had elevated bilirubin >1.3 mg/dL. Overall, 35 (9.3%) patients had viral load >1000 copies/ml (virological failure). Among the virologically failing vs. non-failing patients, bilirubin was elevated in 34.3% vs. 72.0% respectively (p < 0.001), although adherence by pill count was similar (62.9% vs. 60.7%, p = 0.804). The odds of virological failure were higher for adults aged 25-40 years (adjusted odds ratio (aOR) 2.5, p = 0.048), those with CD4 cell count <100 (aOR 17.5, p < 0.001), and those with normal bilirubin levels (aOR 5.4, p < 0.001); but were lower for the overweight/obese patients (aOR 0.3, p = 0.026). Poor pill count adherence (aOR 0.7, p = 0.4) and male gender (aOR 1.2, p = 0.698) were not associated with second line virological failure. CONCLUSIONS: Among patients receiving atazanavir/ritonavir-based second line antiretroviral therapy, bilirubin levels better predicted virological failure than pill count adherence. Therefore, strategic use of bilirubin and viral load testing to target adherence counseling and support may be cost-effective in monitoring second line antiretroviral therapy adherence and virological failure. Drug resistance testing targeted for patients with virological failure despite elevated bilirubin levels would facilitate timely switch to third line antiretroviral regimens whenever available

Baseline characteristics of study sites and women enrolled in a three-arm cluster randomized controlled trial: PMTCT uptake and retention (pure) Malawi

Abstract Background Malawi introduced an ambitious public health program known as “Option B+” which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of WHO clinical stage or CD4 cell count. The PMTCT Uptake and REtention (PURE) study aimed at evaluating the effect of peer-support on care-seeking and retention in care. Methods/design PURE Malawi was a three-arm cluster randomized controlled trial that compared facility-based and community-based models of peer support to standard of care under Option B+ strategy. Each arm was expected to enroll a minimum of 360 women with a total minimum sample size of 1080 participants. 21 sites (clusters) were selected for inclusion in the study. This paper describes the site selection, recruitment, enrollment process and baseline characteristics of study sites and women enrolled in the trial. Results Study implementation was managed by 3 partner organizations; each responsible for 7 study sites. The trial was conducted in the South East, South West, and Central West zones of Malawi, the zones where the implementing partners operate. Study sites included 2 district hospitals, 2 mission hospitals, 2 rural hospitals, 13 health centers and 1 private clinic. Enrollment occurred from November 2013 to November 2014, over a median period of 31 weeks (range 17–51) by site. A total of 1269 HIV-infected pregnant (1094) and breastfeeding (175) women, who were eligible to initiate ART under Option B+, were enrolled. Each site reached or surpassed the minimum sample size. Comparing the number of women enrolled versus antenatal cohort reports, sites recruited a median of 90% (IQR 75–100) of eligible reported women. In the majority of sites the ratio of pregnant and lactating women enrolled in the study was similar to the ratio of reported pregnant and lactating women starting ART in the same sites. The median age of all women was 27 (IQR 22–31) years. All women have ≥20 months of possible follow-up time; 96% ≥ 2 years (24–32 months). Conclusion The PURE Malawi study showed that 3 implementing partner organizations could successfully recruit a complex cohort of pregnant and lactating women across 3 geographical zones in Malawi within a reasonable timeline. Trial registration This study is registered at clinicaltrials.gov - ID Number NCT02005835 . Registered 4 December, 2013

The value of informal care in the context of option B+ in Malawi: a contingent valuation approach

Abstract Background Informal care, the health care provided by the patient’s social network is important in low income settings although its monetary value is rarely estimated. The lack of estimates of the value of informal care has led to its omission in economic evaluations but this can result in incorrect decisions about cost effectiveness of an intervention. We explore the use of contingent valuation methods of willingness to pay (WTP) and willingness to accept (WTA) to estimate the value of informal care provided to HIV infected women that are accessing antiretroviral therapy (ART) under the Option B+ approach to prevention of mother-to-child transmission (PMTCT) of HIV in Malawi. Methods We collected cross sectional data from 93 caregivers of women that received ART care from six health facilities in Malawi. Caregivers of women that reported for ART care on the survey day and consented to participate in the survey were included until the targeted sample size for the facility was reached. We estimated the value of informal care by using the willingness to accept (WTA) and willingness to pay (WTP) approaches. Medians were used to summarize the values and these were compared by the Wilcoxon signed-rank test. Results The median WTA to provide informal care in a month was US$30 and the median WTP for informal care was US$13 and the two were statistically different (p < 0.000). Median WTP was higher in the urban areas than in the rural areas (US$21 vs. US$13, p < 0.001) and for caregivers from households from higher wealth quintile than in the lower quintile (US$15 vs. US$13, p < 0.0462). Conclusion Informal caregivers place substantial value on informal care giving. In low income settings where most caregivers are not formally employed, WTP and WTA approaches can be used to value informal care. Clinical trial number NCT02005835

Beyond statistics: the cumulative effect of vulnerability in management of HIV

Thesis (Ph.D.)--University of Washington, 2019Background: Health outcomes of antiretroviral therapy (ART) are well studied, while the psychosocial processes of seeking clinical care and adhering to lifelong medications to achieve viral suppression are understudied. This study explores how vulnerability to HIV and in the context of HIV affect individuals’ decisions as they start self-management of HIV. Methods: This study utilized mixed methods to obtain information from persons newly diagnosed with HIV at an urban high-patient load facility in Lilongwe, Malawi. First, a one-time survey of 151 persons newly diagnosed with HIV was used to generate information on individual- and social-level factors of intent to start and follow antiretroviral treatment. As a follow-up, in-depth interviews were conducted with 26 of the survey participants to explore how cumulative vulnerability affected their intent and actual follow-up of clinical care during the initial 6-month period. Linear regression analysis was used to assess the effect of vulnerability on intent to follow clinical care, while multinomial regression analysis was used to assess effect of vulnerability on actual 6-month follow-up status. A grounded theory approach was used to organize and analyze qualitative data and prepare them to a synthesized narrative. Results: By the time HIV-related services were sought, newly diagnosed persons reported experiencing persistent sickness, disrupted relationships and behavior guided by societal gender norms. Given the demonstrated outcomes of initiating ART early, participants welcomed initiation of ART but were unsure how they could manage stigma. They feared experiencing changes in appearance, being labelled as someone who has had reckless sexual experience, having limited fertility options, including partner choices, and needing more than usual resources to care for their compromised health. Intent to follow clinical care was not associated with age and gender. It was, however, independently associated with education level, recent physical health conditions, reason for current HIV testing and anticipation of sustained support from core social network after disclosure. Whether individuals reported having current social support did not affect their intent to follow care. However, those who anticipated sustained social support were highly likely to intend to follow care. In the initial months of self-management of HIV, the need to attend to additional health conditions resulted in added pill burden and clinic visits. Once good health was regained, it enabled dignity and resumed social activities. Emotional, physical and financial support were sought and obtained from current marital and non-marital partners, kin (siblings, parents and children), and close friends. Facility- and community-based social groups provided financial and emotional support, while religious framework provided emotional support. Conclusions: Newly diagnosed individuals had existing vulnerabilities that led to their HIV infection and acquired new vulnerabilities once diagnosed with HIV. Consideration of continuing to take ART needed constant weighing of stigma. Anticipation of sustained social support facilitated clinical care follow-up. Those who have sustained social support demonstrated resilience, despite being vulnerable. Public health approaches should consider complementing clinical services with facilitation of social support for newly diagnosed individuals, in order to achieve positive health outcomes

Contraceptive use and pregnancy rates among women receiving antiretroviral therapy in Malawi: a retrospective cohort study

Abstract Background In 2011, family planning (FP) services were integrated at Martin Preuss Centre (MPC), in urban Lilongwe, Malawi. To date, no previous study evaluated pregnancy rates among HIV-positive women after the integration of FP services into HIV care at the facility. In this study, we investigated whether integration of FP services into HIV clinical care led to increased use of contraceptives and decreased pregnancy rates. Methods This was a retrospective cohort analysis of HIV-positive women from 15 to 49 years of age who accessed antiretroviral therapy (ART) services at MPC. Ascertainment of FP needs, contraceptive methods and pregnancy status were done at ART initiation, and at each ART follow-up visit. Women were offered a wide range of contraceptive methods. Outcomes of interest were contraceptive use and rate of pregnancy. Incident pregnancy was ascertained through patient self-reports during clinic consultation. Trends of contraceptive use and pregnancy rates were analyzed using chi-square (χ2). Results A total of 10,472 women were included in the analysis and contributed 15,700 person-years of observation. Contraceptive use among all women receiving ART increased from 28% in 2012 to 62% in 2016 (p < 0.001). A total of 501 pregnancies occurred, including 13 multiple pregnancies, resulting in an overall pregnancy rates of 3.2 per 100 person-years. Rates of pregnancy decreased from 6.8 per 100 person-years in 2012 to 1.3 per 100 person-years in 2016 (p < 0.001). Conclusion Integration of FP services into HIV care resulted in increased contraceptive use and, subsequently, decreased pregnancy rates in women receiving ART. HIV programs should consider offering FP services to women who are receiving ART