Consistent use of a combination product versus a single product in a safety trial of the diaphragm and microbicide in Harare, Zimbabwe.

BACKGROUND: We examined the use and acceptability of a combination product (diaphragm and gel) compared to a single product (gel) during a 6-month safety trial in Zimbabwe. STUDY DESIGN: Women were randomized to the use of a diaphragm with gel or the use of gel alone, in addition to male condoms. Ever use and use of study product on the last act of sexual intercourse were assessed monthly by Audio Computer-Assisted Self-Interviewing. Acceptability, correct use and consistent use (use at every sexual act during the previous 3 months) were measured on the last visit by face-to-face interview. Predictors of consistent use were examined using multivariate logistic regression analyses. RESULTS: In this sample of 117 sexually active, monogamous, contracepting women, rates of consistent use were similar in both groups (59.7% for combination method vs. 56.4% for gel alone). Product acceptability was high, but was not independently associated with consistent use. Independent predictors of consistent use included age [adjusted odds ratio (AOR)=1.08; 95% confidence interval (95% CI)=1.01-1.16], consistent condom use (AOR=3.85; 95% CI=1.54-9.63) and having a partner who approves of product use (AOR=2.66; 95% CI=1.10-6.39). CONCLUSIONS: Despite high reported acceptability and few problems with the products, the participants reported only moderate product adherence levels. Consistent use of condoms and consistent use of products were strongly associated. If observed in other studies, this may bias the estimation of product effectiveness in future trials of female-controlled methods

Examining the Determinants of Sexual Violence Among Young, Married Women in Southern India

The prevalence of sexual violence is increasingly being studied in India. Yet the determinants of sexual violence, irrespective of physical violence, remain largely unexplored. Here the authors identify the determinants of sexual violence, and additionally, explore how the presence of physical violence modifies these determinants. A cross-sectional analysis is conducted using baseline data from a longitudinal study involving young married women attending reproductive health clinics in Southern India. A multivariable logistic regression analysis is conducted to first identify determinants of sexual violence and then repeated after stratifying elements based on presence or absence of physical violence identified from participants’ reports. 36% and 50% of the participants report experiencing sexual and physical violence, respectively. After adjusting for other covariates, women’s partners’ characteristics are found most significantly associated with their odds of experiencing sexual violence. These characteristics include husbands’ primary education, employment as drivers, alcohol consumption, and having multiple sex partners. Women’s contribution to household income also increases their odds of experiencing sexual violence by almost twofold; however, if they are solely responsible for “all” household income, the relationship is found to be protective. Physical violence modifies the determinants of sexual violence, and among women not experiencing physical violence, husbands’ primary education and employment as drivers increase women’s odds of experiencing sexual violence nearly threefold, and women who contribute “all” the household income (n = 62) do not experience sexual violence. These relationships are not significant among women experiencing physical violence. Study findings improve the understanding of the determinants of sexual violence. Future research is needed to examine the risk factors for different types of GBV independently and to tease apart the differences in risk factors depending on women’s experiences. The significance of male partners’ characteristics warrants in-depth research, and in order to promote gender-equitable norms, future interventions need to focus on male behaviors and men’s day-to-day survival challenges, all of which likely influence conflicts in marital relationships

Facility-based delivery in the context of Zimbabwe's HIV epidemic--missed opportunities for improving engagement with care: a community-based serosurvey.

BackgroundIn developing countries, facility-based delivery is recommended for maternal and neonatal health, and for prevention of mother-to-child HIV transmission (PMTCT). However, little is known about whether or not learning one's HIV status affects one's decision to deliver in a health facility. We examined this association in Zimbabwe.MethodsWe analyzed data from a 2012 cross-sectional community-based serosurvey conducted to evaluate Zimbabwe's accelerated national PMTCT program. Eligible women (≥16 years old and mothers of infants born 9-18 months before the survey) were randomly sampled from the catchment areas of 157 health facilities in five of ten provinces. Participants were interviewed about where they delivered and provided blood samples for HIV testing.ResultsOverall 8796 (77 %) mothers reported facility-based delivery; uptake varied by community (30-100%). The likelihood of facility-based delivery was not associated with maternal HIV status. Women who self-reported being HIV-positive before delivery were as likely to deliver in a health facility as women who were HIV-negative, irrespective of when they learned their status - before (adjusted prevalence ratio (PRa) = 1.04, 95% confidence interval (CI) = 1.00-1.09) or during pregnancy (PRa = 1.05, 95% CI = 1.01-1.09). Mothers who had not accessed antenatal care or tested for HIV were most likely to deliver outside a health facility (69%). Overall, however 77% of home deliveries occurred among women who had accessed antenatal care and were HIV-tested.ConclusionsUptake of facility-based delivery was similar among HIV-infected and HIV-uninfected mothers, which was somewhat unexpected given the substantial technical and financial investment aimed at retaining HIV-positive women in care in Zimbabwe

Predictors of incident herpes simplex virus type 2 infections in young women at risk for unintended pregnancy in San Francisco.

BackgroundYoung women receiving family planning services are at risk for both unintended pregnancy and herpes simplex virus type 2 (HSV-2) infection.MethodsWe performed a secondary analysis using data from a previously published randomized controlled trial evaluating access to emergency contraception on reproductive health outcomes. Women aged 15 to 24 years were recruited from two Planned Parenthood clinics and two community health clinics in San Francisco. Demographic information and sexual history were obtained by interview. HSV-2 seropositivity was determined by fingerstick blood test. New pregnancies were measured by self-report, urine testing and medical chart review. Subjects were evaluated for incident HSV-2 infection and pregnancy at a 6-month follow-up appointment. Women who were pregnant or intending to become pregnant at enrolment were excluded.ResultsAt enrolment 2,104 women were screened for HSV-2 and 170 (8.1%) were seropositive. Eighty-seven percent of initially seronegative women completed the study (n = 1,672) and 73 (4.4%) became HSV-2 seropositive. HSV-2 seroincidence was 7.8 cases per 100 person-years. One hundred and seventeen women (7%) became pregnant and 7 (6%) of these had a seroincident HSV-2 infection during the study. After adjustment for confounders, predictors of incident HSV-2 infection were African American race and having multiple partners in the last six months. Condom use at last sexual encounter was protective.ConclusionHSV-2 seroincidence and the unintended pregnancy rate in young women were high. Providers who counsel women on contraceptive services and sexually transmitted infection prevention could play an expanded role in counselling women about HSV-2 prevention given the potential sequelae in pregnancy. The potential benefit of targeted screening and future vaccination against HSV-2 needs to be assessed in this population

Unmet need for family planning, contraceptive failure, and unintended pregnancy among HIV-infected and HIV-uninfected women in Zimbabwe.

BackgroundPrevention of unintended pregnancies among women living with HIV infection is a strategy recommended by the World Health Organization for prevention of mother-to-child transmission of HIV (PMTCT). We assessed pregnancy intentions and contraceptive use among HIV-positive and HIV-negative women with a recent pregnancy in Zimbabwe.MethodsWe analyzed baseline data from the evaluation of Zimbabwe's Accelerated National PMTCT Program. Eligible women were randomly sampled from the catchment areas of 157 health facilities offering PMTCT services in five provinces. Eligible women were ≥16 years old and mothers of infants (alive or deceased) born 9 to 18 months prior to the interview. Participants were interviewed about their HIV status, intendedness of the birth, and contraceptive use.ResultsOf 8,797 women, the mean age was 26.7 years, 92.8% were married or had a regular sexual partner, and they had an average of 2.7 lifetime births. Overall, 3,090 (35.1%) reported that their births were unintended; of these women, 1,477 (47.8%) and 1,613 (52.2%) were and were not using a contraceptive method prior to learning that they were pregnant, respectively. Twelve percent of women reported that they were HIV-positive at the time of the survey; women who reported that they were HIV-infected were significantly more likely to report that their pregnancy was unintended compared to women who reported that they were HIV-uninfected (44.9% vs. 33.8%, p<0.01). After adjustment for covariates, among women with unintended births, there was no association between self-reported HIV status and lack of contraception use prior to pregnancy.ConclusionsUnmet need for family planning and contraceptive failure contribute to unintended pregnancies among women in Zimbabwe. Both HIV-infected and HIV-uninfected women reported unintended pregnancies despite intending to avoid or delay pregnancy, highlighting the need for effective contraceptive methods that align with pregnancy intentions

Detailed Version: Analyzing Direct Effects in Randomized Trials with Secondary Interventions: An Application to HIV Prevention Trials

This is the detailed technical report that accompanies the paper “Analyzing Direct Effects in Randomized Trials with Secondary Interventions: An Application to HIV Prevention Trials” (an unpublished, technical report version of which is available online at http://www.bepress.com/ucbbiostat/paper223). The version here gives full details of the models for the time-dependent analysis, and presents further results in the data analysis section. The Methods for Improving Reproductive Health in Africa (MIRA) trial is a recently completed randomized trial that investigated the effect of diaphragm and lubricant gel use in reducing HIV infection among susceptible women. 5,045 women were randomly assigned to either the active treatment arm or not. Additionally, all subjects in both arms received intensive condom counselling and provision, the gold standard HIV prevention barrier method. There was much lower reported condom use in the intervention arm than in the control arm, making it difficult to answer important public health questions based solely on the intention-to-treat analysis. We adapt an analysis technique from causal inference to estimate the direct effects of assignment to the diaphragm arm, adjusting for condom use in an appropriate sense. Issues raised in the MIRA trial apply to other trials of HIV prevention methods, some of which are currently being conducted or designed

Understanding preferences for HIV care and treatment in Zambia: evidence from a discrete choice experiment among patients who have been lost to follow-up

Background: In public health HIV treatment programs in Africa, long-term retention remains a challenge. A number of improvement strategies exist (e.g., bring services closer to home, reduce visit frequency, expand hours of clinic operation, improve provider attitude), but implementers lack data about which to prioritize when resource constraints preclude implementing all. We used a discrete choice experiment (DCE) to quantify preferences for a number of potential clinic improvements to enhance retention. Methods and findings: We sought a random sample of HIV patients who were lost to follow-up (defined as >90 days late for their last scheduled appointment) from treatment facilities in Lusaka Province, Zambia. Among those contacted, we asked patients to choose between 2 hypothetical clinics in which the following 5 attributes of those facilities were varied: waiting time at the clinic (1, 3, or 5 hours), distance from residence to clinic (5, 10, or 20 km), ART supply given at each refill (1, 3, or 5 months), hours of operation (morning only, morning and afternoon, or morning and Saturday), and staff attitude ("rude" or "nice"). We used mixed-effects logistic regression to estimate relative utility (i.e., preference) for each attribute level. We calculated how much additional waiting time or travel distance patients were willing to accept in order to obtain other desired features of care. Between December 9, 2015 and May 31, 2016, we offered the survey to 385 patients, and 280 participated (average age 35; 60% female). Patients exhibited a strong preference for nice as opposed to rude providers (relative utility of 2.66; 95% CI 1.9–3.42; p < 0.001). In a standard willingness to wait or willingness to travel analysis, patients were willing to wait 19 hours more or travel 45 km farther to see nice rather than rude providers. An alternative analysis, in which trade-offs were constrained to values actually posed to patients in the experiment, suggested that patients were willing to accept a facility located 10 km from home (as opposed to 5) that required 5 hours of waiting per visit (as opposed to 1 hour) and that dispensed 3 months of medications (instead of 5) in order to access nice (as opposed to rude) providers. This study was limited by the fact that attributes included in the experiment may not have captured additional important determinants of preference. Conclusions: In this study, patients were willing to expend considerable time and effort as well as accept substantial inconvenience in order to access providers with a nice attitude. In addition to service delivery redesign (e.g., differentiated service delivery models), current improvement strategies should also prioritize improving provider attitude and promoting patient centeredness—an area of limited policy attention to date

Pregnancy Intentions and Teenage Pregnancy Among Latinas: A Mediation Analysis

The extent to which pregnancy intentions mediate the relationship between individual, familial and cultural characteristics and adolescent pregnancy is not well understood. The role of intentions may be particularly important among Latina teenagers, whose attitudes toward pregnancy are more favorable than those of other groups and whose pregnancy rates are high