Background. Data evaluating the biological events and determinants of early human immunodeficiency virus type 1 (HIV-1) infection are limited in sub-Saharan Africa. We examined plasma viral levels ...and trends during early and established HIV-1 infection among reproductive-age women who participated in a randomized trial to treat genital tract infection in Malawi. We also assessed the association of injectable hormonal contraceptive use with HIV-1 infection. Methods. We studied 3 groups of women who were infected or uninfected with HIV-1: seroconverters, seroprevalent women, and seronegative women. Questionnaires and blood samples were collected at baseline and every 3 months for 1 year. The virus set point in seroconverters and levels and trends of viral load over time were determined. The associations of injectable hormonal contraceptive use with HIV-1 infection and viral load were assessed using conditional logistic regression and mixed-effect models, respectively. Results. In the original clinical trial, 844 women infected with HIV-1 and 842 women not infected with HIV-1 were enrolled. Of 31 women who experienced seroconversion during 12 months, 27 were matched with 54 seroprevalent and 54 seronegative women. The estimated median plasma virus set point was 4.45 log10 copies/mL (interquartile range, 4.32–5.14 log10 copies/mL). Injectable hormonal contraceptive use was significantly associated with HIV-1 seroconversion (adjusted odds ratio, 10.42; P=.03) but not with established HIV-1 infection. Among the seroconverters, a statistically significant interaction was found between the linear association of viral load and time of injectable hormonal contraceptive use (regression coefficient, −0.14; P=.02). Conclusion. Knowledge of virus set point and trends of viral load in HIV-1 seroincident and seroprevalent asymptomatic women could assist in antiretroviral treatment management.
(Abstracted from N Engl J Med 2016; DOI10.1056/NEJMoa1506110)The objective of this study was to examine the efficacy of dapivirine vaginal rings in providing protection against human immunodeficiency ...virus type 1 (HIV-1). HIV-1 infection incidence is one of the highest in sub-Saharan Africa.
Patient satisfaction is an individual's state of being content with the care provided in the health system. It is important for reproductive health care providers to get feedback from women regarding ...satisfaction with reproductive health services. There is a dearth of knowledge about patient satisfaction in Malawi.
The specific objective of the study was to determine the extent to which women are satisfied with the care they receive when they come to deliver at the Queen Elizabeth Central Hospital maternity unit.
A cross sectional study of postpartum women using interviewer administered semi-structured questionnaires was conducted between November 2008 and May 2009. The questionnaires captured mainly quantitative data.
1562 women were interviewed. Most women were housewives (79%) who were referred from Health Centres within the city. Ninety five percent delivered a live baby. The majority of women (97.3%) were satisfied with the care they received from admission through labour and delivery and the immediate postpartum period. Most women cited doctors' and nurses' reviews (65%) as what they liked most about the care they received during their stay in the unit. Most women expected to receive efficient and definitive care. The women's knowledge on patient's rights was extremely low (16%) and equally very few women were offered an opportunity to give an opinion regarding their care by the doctors and nurses in the maternity unit.
Most women who deliver at the hospital are satisfied with the care offered. This satisfaction is mainly due to the frequent reviews of patients by nurses and doctors in the unit. There is a great need to educate both the population of women served and the health workers that serve them on patient's rights.
Abstract Objective To determine the factors associated with resumption of sexual activity and regular menses after childbirth among women infected with HIV-1. Methods Information on sociodemographic, ...behavioral, and clinical factors was obtained from 2 HIV perinatal studies (NVAZ and PEPI trials) conducted in Malawi, 2000–2009. Factors associated with resumption of sexual activity and menses were analyzed using Cox proportional hazard models. Results A total of 1838 women from the NVAZ study and 2982 women from the PEPI study were included in the analysis. Resumption of sexual activity was primarily associated with sociodemographic factors (e.g. in the PEPI study, marital status adjusted hazard ratio (aHR) 0.56, P < 0.001, use of contraceptive method aHR 8.0, P < 0.001, and breastfeeding aHR 0.52, P < 0.001), whereas resumption of regular menses in the PEPI study was primarily associated with biological factors (e.g. plasma viral load aHR 0.89, P < 0.006, and breastfeeding aHR 0.23, P < 0.001). Conclusion HIV-infected women need adequate counseling to take into account their HIV infection status before resuming sexual activity after childbirth.
Background: IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes ...for women in the study who were randomized to continue or discontinue ART after delivery.
Methods: Women with pre-ART CD4+ cell counts ≥350 cells/mm
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who started ART during pregnancy were randomized postpartum to continue or discontinue treatment. Women were enrolled from India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. The primary outcome was a composite of progression to AIDS-defining illness or death. Log-rank tests and Cox regression models assessed treatment effects. Incidence rates were calculated per 100 person-years. A post hoc analysis evaluated WHO Stage 2/3 events. All analyses were intent-to-treat.
Findings: 1611 women were enrolled (June 2011-October 2014) and 95% were breastfeeding. Median age at entry was 27 years, CD4+ count 728 cells/mm
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and the majority of women were Black African (97%). After a median follow-up of 1.6 years, progression to AIDS-defining illness or death was rare and there was no significant difference between arms (HR: 0·55; 95%CI 0·14, 2·08, p = 0.37). WHO Stage 2/3 events were reduced with continued ART (HR: 0·60; 95%CI 0·39, 0·90, p = 0.01). The arms did not differ with respect to the rate of grade 2, 3, or 4 safety events (p = 0.61).
Interpretation: Serious clinical events were rare among predominately breastfeeding women with high CD4+ cell counts over 18 months after delivery. ART had significant benefit in reducing WHO 2/3 events in this population.
Assess efficacy of intermittent intravaginal metronidazole gel treatment in reducing frequency of bacterial vaginosis (BV).
Randomized, double-masked, placebo-controlled phase 3 trial.
Postnatal and ...family planning clinics of the Queen Elizabeth Central Hospital and two health centers in Blantyre, Malawi.
Nonpregnant HIV-uninfected and -infected women.
Intravaginal metronidazole treatment and placebo gels provided at baseline and every 3 mo for 1 y.
PRIMARY: Cross-sectional and longitudinal comparisons of BV frequency at baseline, 1 mo after product dispensation (post-treatment evaluation PTE), and every quarterly visit. Secondary: Effect of treatment on BV clearance and recurrence.
BASELINE: 842 HIV-uninfected and 844 HIV-infected women were enrolled. The frequency of BV at baseline in treatment and placebo arms, respectively, was 45.9% and 46.8% among HIV-uninfected women, and 60.5% and 56.9% among HIV-infected women.
At the PTEs the prevalence of BV was consistently lower in treatment than placebo arms irrespective of HIV status. The differences were statistically significant mainly in HIV-uninfected women. Prevalence of BV was also reduced over time in both treatment and placebo arms. In a multivariable analysis that controlled for other covariates, the effect of intravaginal metronidazole treatment gel compared with placebo was not substantial: adjusted relative risk (RR) 0.90, 95% confidence interval (CI) 0.83-0.97 in HIV-uninfected women and adjusted RR 0.95, 95% CI 0.89-1.01 in HIV-infected women.
Intravaginal metronidazole treatment gel significantly increased BV clearance (adjusted hazard ratio HR 1.34, 95% CI 1.07-1.67 among HIV-uninfected women and adjusted HR 1.29, 95% CI 1.06-1.58 among HIV-infected women) but was not associated with decreased BV recurrence.
No serious adverse events were related to use of intravaginal gels.
Intermittent microbicide treatment with intravaginal gels is an innovative approach that can reduce the frequency of vaginal infections such as BV.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background: As the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established ...a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort.
Methods: Initiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing.
Results: MTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness.
Conclusions: Enrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.
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