Clinical trials have found that a monthly dapivirine vaginal ring was well-tolerated and reduced HIV-1 risk among women in sub-Saharan Africa. However, in order for the ring or other novel prevention ...methods to have optimal impact, it is necessary to understand and address women's challenges to uptake and adherence. This paper provides insight into a few key challenges noted by women using the ring and contraceptives simultaneously.
The qualitative portion of the MTN-020/ASPIRE study consisted of data collection using single in-depth interviews, serial in-depth interviews, and focus group discussions, conducted with 214 participants across 15 sites in Malawi, South Africa, Uganda and Zimbabwe. A coding team used qualitative analysis software to identify themes within the interviews.
The primary qualitative themes among participant data pertained to side effects. Participants reported negative side effects related to menses, in some cases attributing these effects to their contraceptives and in others to the vaginal ring. Participants also expressed concern over the long-term impact of contraception and ring use on fertility, including the reversibility of the contraceptive, especially among nulliparous women.
Women's attitudes toward contraceptives can impact their willingness to concurrently use and adhere to a novel HIV prevention product. To optimize the potential of both prevention products, researchers should pre-emptively address concerns about contraceptive impact on fertility and counsel women about the expected side effects of contraceptives versus the ring. Clinical trials identifier NCT01617096. Registered on 6-12-2012 at clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01617096.
The objective of this study was to describe the impact of intense counseling to reduce vaginal hygiene practices and its effect on bacterial vaginosis. A secondary data analysis of the HIV Prevention ...Trials Network 035 study was undertaken, focusing on HIV-negative, nonpregnant women who were at least 18 years old, in seven African sites and one US site. At enrollment and during follow-up quarterly visits, vaginal hygiene practices were determined by face-to-face administration of a behavioral assessment questionnaire. Vaginal hygiene practices were categorized as insertion into the vagina of (1) nothing, (2) water only, and (3) other substances with or without water. Each practice was quantified by frequency and type/combination of inserted substances. At quarterly visits, diagnosis of bacterial vaginosis was made using the Nugent score. Trends for vaginal hygiene practices and bacterial vaginosis were evaluated using generalized estimating equation models. A total of 3087 participants from the HIV Prevention Trials Network 035 study were eligible for this analysis. At enrollment, 1859 (60%) reported recent vaginal hygiene practices. By one year, this figure had decreased to 1019 (33%) with counseling. However, bacterial vaginosis prevalence remained consistent across the study observation period, with 36%-38% of women testing positive for the condition ( p for trend = 0.27). Overall, those who reported douching with water only (AOR = 1.03, 95%CI: 0.94-1.13) and those who reported inserting other substances (AOR= 0.98, 95%CI: 0.88-1.09) in the past quarter were not more likely to have bacterial vaginosis compared to those who reported no insertions. However, in South Africa, an increase in bacterial vaginosis was seen among those who reported inserting other substances (AOR: 1.48, 95%CI: 1.17, 1.88). In conclusion, targeted counseling against vaginal hygiene practices resulted in change in self-reported behavior but did not have an impact on bacterial vaginosis diagnosis in all but one site.
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.
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.
Women with pre-ART CD4+ cell counts ≥350 cells/mm
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.
1611 women were enrolled (June 2011-October 2014) and 95% were breastfeeding. Median age at entry was 27 years, CD4+ count 728 cells/mm
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).
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.
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