Financial incentives to promote retention in care and viral suppression in adults with HIV initiating antiretroviral therapy in Tanzania: a three-arm randomised controlled trial.

BACKGROUND: Financial incentives promote use of HIV services and might support adherence to the sustained antiretroviral therapy (ART) necessary for viral suppression, but few studies have assessed a biomarker of adherence or evaluated optimal implementation. We sought to determine whether varying sized financial incentives for clinic attendance effected viral suppression in patients starting ART in Tanzania. METHODS: In a three-arm, parallel-group, randomised controlled trial at four health facilities in Shinyanga region, Tanzania, adults aged 18 years or older with HIV who had started ART within the past 30 days were randomly assigned (1:1:1) using a tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10 000 Tanzanian Shillings (TZS; about US$4·50) or 22 500 TZS (about $10·00). There were no formal exclusion criteria. Participants were masked to the existence of two incentive sizes. Incentives were provided for up to 6 months via mobile health technology (mHealth) that linked biometric attendance monitoring to automated mobile payments. We evaluated the primary outcome of retention in care with viral suppression (<1000 copies per mL) at 6 months using logistic regression. This trial is registered with ClinicalTrials.gov, NCT03351556. FINDINGS: Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group). All participants were included in the primary intention-to-treat analysis. At 6 months, approximately 134 (73%) participants in the control group remained in care and had viral suppression, compared with 143 (83%) in the smaller incentive group (risk difference [RD] 9·8, 95% CI 1·2 to 18·5) and 150 (86%) in the larger incentive group (RD 13·0, 4·5 to 21·5); we identified a positive trend between incentive size and viral suppression (p trend=0·0032), although the incentive groups did not significantly differ (RD 3·2, -4·6 to 11·0). Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation. INTERPRETATION: Small financial incentives delivered using mHealth can improve retention in care and viral suppression in adults starting HIV treatment. Although further research should investigate the durability of effects from short-term incentives, these findings strengthen the evidence for implementing financial incentives within standard HIV care. FUNDING: National Institute of Mental Health at the US National Institutes of Health.

The heterogeneous effect of short-term transfers for improving ART adherence among HIV-infected Tanzanian adults

A recently concluded randomized study in Tanzania found that short-term conditional cash and food transfers significantly improved HIV-infected patients' possession of antiretroviral therapy (ART) and reduced patient loss to follow-up (LTFU) (McCoy, S. I., Njau, P. F., Fahey, C., Kapologwe, N., Kadiyala, S., Jewell, N. P., & Padian, N. S. (2017). Cash vs. food assistance to improve adherence to antiretroviral therapy among HIV-infected adults in Tanzania. AIDS, 31(6), 815­825. doi:10.1097/QAD.0000000000001406 ). We examined whether these transfers had differential effects within population subgroups. In the parent study, 805 individuals were randomized to one of three study arms: standard-of-care (SOC) HIV services, food assistance, or cash transfer. We compared achievement of the medication possession ratio (MPR) ≥ 95% at 6 and 12 months and patient LTFU at 12 months between those receiving the SOC and those receiving food or cash (combined). Using a threshold value of p < 0.20 to signal potential effect measure modifiers (EMM), we compared intervention effects, expressed as risk differences (RD), within subgroups characterized by: sex, age, wealth, and time elapsed between HIV diagnosis and ART initiation. Short-term transfers improved 6 and 12-month MPR ≥ 95% and reduced 12-month LTFU in most subgroups. Study results revealed wealth and time elapsed between HIV diagnosis and ART initiation as potential EMMs, with greater effects for 6-month MPR ≥ 95% in the poorest patients (RD: 32, 95% CI: (9, 55)) compared to those wealthier (RD: 16, 95% CI: (5, 27); p = 0.18) and in newly diagnosed individuals (<90 days elapsed since diagnosis) (RD: 25, 95% CI: (13, 36)) compared to those with ≥90 days (RD: 0.3, 95% CI (−17, 18); p = 0.02), patterns which were sustained at 12 months. Results suggest that food and cash transfers may have stronger beneficial effects on ART adherence in the poorest patients. We also provide preliminary data suggesting that targeting interventions at patients more recently diagnosed with HIV may be worthwhile. Larger and longer-term assessments of transfer programs for the improvement of ART adherence and their potential heterogeneity by sub-population are warranted.

Nonadherence to antiretroviral therapy among HIV-infected patients in Zambia is concentrated among a minority of patients and is highly variable across clinics.

OBJECTIVES: The distribution of adherence to antiretroviral therapy (ART) can indicates whether barriers are concentrated or more distributed. We quantified the medication possession ratio (MPR) and characterized the distribution of medication nonpossession in a network of clinics in Zambia to identify 'hotspots' and predictors of poorer adherence. METHODS: We analyzed a population of adults on ART for more than 3 months who made at least one clinic visit between 1 January 2013 and 28 February 2015. Pharmacy refill and clinical information were obtained through the electronic medical record system used in routine care. We constructed a Lorenz curve to visualize the distribution of poor adherence and used a multilevel logistic regression model to examine factors associated with MPR. RESULTS: Among 131 767 patients in 56 clinics [64% women, median age 34 years (interquartile range (IQR) 29-41), median CD4 cell count at ART initiation 351 cells/µl (IQR 220-517)], the median MPR was 85.8% (IQR 70.8-96.8). During months 7-12 on ART, 45.6% of patients had 100% MPR and 10.5% accounted for 50% of medication nonpossession. Across clinics, median MPR ranged from 49.1 to 98.5, and clinic accounted for 12% of the variability in adherence after adjusting for individual and clinic-level characteristics. CONCLUSION: A small fraction of patients account for the majority of days of medication nonpossession. Further characterization of these subpopulations is needed to target interventions. Clinic also accounted for much variability in MPR. Health systems interventions targeting clinic 'hot spots' may represent an efficient use of resources to improve ART adherence.

Cash vs. food assistance to improve adherence to antiretroviral therapy among HIV-infected adults in Tanzania.

OBJECTIVE: We evaluated the effectiveness of short-term cash and food assistance to improve adherence to antiretroviral therapy (ART) and retention in care among people living with HIV in Tanzania. METHODS: At three clinics, 805 participants were randomized to three groups in a 3 : 3 : 1 ratio, stratified by site : nutrition assessment and counseling (NAC) and cash transfers (∼$11/month, n = 347), NAC and food baskets (n = 345), and NAC-only (comparison group, n = 113, clinicaltrials.gov NCT01957917). Eligible people living with HIV were at least 18 years, initiated ART 90 days or less prior, and food insecure. Cash or food was provided for 6 or less consecutive months, conditional on visit attendance. The primary outcome was medication possession ratio (MPR ≥ 95%) at 6 months. Secondary outcomes were appointment attendance and loss to follow-up (LTFU) at 6 and 12 months. RESULTS: The primary intent-to-treat analysis included 800 participants. Achievement of MPR ≥ 95% at 6 months was higher in the NAC + cash group compared with NAC-only (85.0 vs. 63.4%), a 21.6 percentage point difference [95% confidence interval (CI): 9.8, 33.4, P < 0.01]. MPR ≥ 95% was also significantly higher in the NAC + food group vs. NAC-only (difference = 15.8, 95% CI: 3.8, 27.9, P < 0.01). When directly compared, MPR ≥ 95% was similar in the NAC + cash and NAC + food groups (difference = 5.7, 95% CI: -1.2, 12.7, P = 0.15). Compared with NAC-only, appointment attendance and LTFU were significantly higher in both the NAC + cash and NAC + food groups at 6 months. At 12 months, the effect of NAC + cash, but not NAC + food, on MPR ≥ 95% and retention was sustained. CONCLUSION: Short-term conditional cash and food assistance improves ART possession and appointment attendance and reduces LTFU among food-insecure ART initiates in Tanzania.

Option A improved HIV-free infant survival and mother to child HIV transmission at 9-18 months in Zimbabwe.

OBJECTIVE: We evaluated the impact of Option A on HIV-free infant survival and mother-to-child transmission (MTCT) in Zimbabwe. DESIGN: Serial cross-sectional community-based serosurveys. METHODS: We analyzed serosurvey data collected in 2012 and 2014 among mother-infant pairs from catchment areas of 132 health facilities from five of 10 provinces in Zimbabwe. Eligible infants (alive or deceased) were born 9-18 months before each survey to mothers at least 16 years old. We randomly selected mother-infant pairs and conducted questionnaires, verbal autopsies, and collected blood samples. We estimated the HIV-free infant survival and MTCT rate within each catchment area and compared the 2012 and 2014 estimates using a paired t test and number of HIV infections averted because of the intervention. RESULTS: We analyzed 7249 mother-infant pairs with viable maternal specimens collected in 2012 and 8551 in 2014. The mean difference in the catchment area level MTCT between 2014 and 2012 was -5.2 percentage points (95% confidence interval = -8.1, -2.3, P < 0.001). The mean difference in the catchment area level HIV-free survival was 5.5 percentage points (95% confidence interval = 2.6, 8.5, P < 0.001). Between 2012 and 2014, 1779 infant infections were averted compared with the pre-Option A regimen. The association between HIV-free infant survival and duration of Option A implementation was NS at the multivariate level (P = 0.093). CONCLUSION: We found a substantial and statistically significant increase in HIV-free survival and decrease in MTCT among infants aged 9-18 months following Option A rollout in Zimbabwe. This is the only evaluation of Option A and shows the effectiveness of Option A and Zimbabwe's remarkable progress toward eMTCT.

Targeting elimination of mother-to-child HIV transmission efforts using geospatial analysis of mother-to-child HIV transmission in Zimbabwe.

BACKGROUND: We assessed Zimbabwe's progress toward elimination of mother-to-child HIV transmission (MTCT) under Option A. METHODS: We analyzed 2012 and 2014 cross-sectional serosurvey data from mother-infant pairs residing in the same 157 health facility catchment areas randomly sampled from five provinces. Eligible women were at least 16 years and mothers/caregivers of infants born 9-18 months prior. We aggregated individual-level questionnaire and HIV serostatus within catchment areas or district to estimate MTCT and the number of HIV-infected infants; these data were mapped using facility global positioning system coordinates. RESULTS: A weighted population of 8800 and 10 404 mother-infant pairs was included from 2012 and 2014, respectively. In 2014, MTCT among HIV-exposed infants was 6.7% (95% confidence interval: 5.2, 8.6), not significantly different from 2012 (8.8%, 95% confidence interval: 6.9, 11.1, P = 0.13). From 2012 to 2014, self-reported antiretroviral therapy or prophylaxis among HIV-infected women increased from 59 to 65% (P = 0.05), as did self-reported infant antiretroviral prophylaxis (63 vs. 67%, P = 0.08). In 2014, 65 (41%), 55 (35%), and 37 (24%) catchment areas had the same, lower, and higher MTCT rate as in 2012, respectively. MTCT in 2014 varied by catchment areas (median = 0%, mean = 4.9%, interquartile range = 0-10%) as did the estimated number of HIV-infected infants (median = 0, mean = 1.1, interquartile range = 0-1.0). Also in 2014, 106 (68%) catchment areas had MTCT = 0%. Geovisualization revealed clustering of catchment areas where both MTCT and the estimated number of HIV-infected infants were relatively high. CONCLUSION: Although MTCT is declining in Zimbabwe, geospatial analysis indicates facility-level variability. Catchment areas with high MTCT rates and a high burden of HIV-infected infants should be the highest priority for service intensification.

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

BACKGROUND: In 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. METHODS: We 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. RESULTS: Overall 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. CONCLUSIONS: Uptake 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.

Rationale and design of a randomized study of short-term food and cash assistance to improve adherence to antiretroviral therapy among food insecure HIV-infected adults in Tanzania.

BACKGROUND: Food insecurity is an important barrier to retention in care and adherence to antiretroviral therapy (ART) among people living with HIV infection (PLHIV). However, there is a lack of rigorous evidence about how to improve food security and HIV-related clinical outcomes. To address this gap, this randomized trial will evaluate three delivery models for short-term food and nutrition support for food insecure PLHIV in Shinyanga, Tanzania: nutrition assessment and counseling (NAC) alone, NAC plus food assistance, and NAC plus cash transfers. METHODS/DESIGN: At three HIV care and treatment sites, 788 participants will be randomized into one of three study arms in a 3:3:1 ratio, stratified by site: NAC plus food assistance, NAC plus cash transfer, and NAC only. Eligible participants are: 1) at least 18 years of age; 2) living with HIV infection; 3) initiated ART in the past 90 days; and 4) food insecure, as measured with the Household Hunger Scale. PLHIV who are severely malnourished (body mass index (BMI) < 16 kg/m(2)) will be excluded. Participants randomized to receive food or cash transfers are eligible to receive assistance for up to six months, conditional on attending regularly scheduled visits with their HIV care provider. Participants will be followed for 12 months: the initial 6-month intervention period and then for another 6 months post-intervention. The primary outcome is ART adherence measured with the medication possession ratio. Secondary outcomes include 1) retention in care; 2) nutritional indicators including changes in food security, BMI, and weight gain; 3) viral suppression and self-reported ART adherence; and 4) participation in the labor force. DISCUSSION: This rigorously designed trial will inform policy decisions regarding supportive strategies for food insecure PLHIV in the early stages of treatment. The study will measure outcomes immediately after the period of support ends as well as 6 months later, providing information on the duration of the interventions' effect. The comparison of food to cash transfers will better inform policies favoring cash assistance or will provide rationale for the continued investment in food and nutrition interventions for PLHIV. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01957917.

Evaluating the Impact of Zimbabwe's Prevention of Mother-to-Child HIV Transmission Program: Population-Level Estimates of HIV-Free Infant Survival Pre-Option A.

OBJECTIVE: We estimated HIV-free infant survival and mother-to-child HIV transmission (MTCT) rates in Zimbabwe, some of the first community-based estimates from a UNAIDS priority country. METHODS: In 2012 we surveyed mother-infant pairs residing in the catchment areas of 157 health facilities randomly selected from 5 of 10 provinces in Zimbabwe. Enrolled infants were born 9-18 months before the survey. We collected questionnaires, blood samples for HIV testing, and verbal autopsies for deceased mothers/infants. Estimates were assessed among i) all HIV-exposed infants, as part of an impact evaluation of Option A of the 2010 WHO guidelines (rolled out in Zimbabwe in 2011), and ii) the subgroup of infants unexposed to Option A. We compared province-level MTCT rates measured among women in the community with MTCT rates measured using program monitoring data from facilities serving those communities. FINDINGS: Among 8568 women with known HIV serostatus, 1107 (12.9%) were HIV-infected. Among all HIV-exposed infants, HIV-free infant survival was 90.9% (95% confidence interval (CI): 88.7-92.7) and MTCT was 8.8% (95% CI: 6.9-11.1). Sixty-six percent of HIV-exposed infants were still breastfeeding. Among the 762 infants born before Option A was implemented, 90.5% (95% CI: 88.1-92.5) were alive and HIV-uninfected at 9-18 months of age, and 9.1% (95%CI: 7.1-11.7) were HIV-infected. In four provinces, the community-based MTCT rate was higher than the facility-based MTCT rate. In Harare, the community and facility-based rates were 6.0% and 9.1%, respectively. CONCLUSION: By 2012 Zimbabwe had made substantial progress towards the elimination of MTCT. Our HIV-free infant survival and MTCT estimates capture HIV transmissions during pregnancy, delivery and breastfeeding regardless of whether or not mothers accessed health services. These estimates also provide a baseline against which to measure the impact of Option A guidelines (and subsequently Option B+).

Implementation and Operational Research: Uptake of Services and Behaviors in the Prevention of Mother-to-Child HIV Transmission Cascade in Zimbabwe.

OBJECTIVE: To examine the uptake of services and behaviors in the prevention of mother-to-child HIV transmission (PMTCT) cascade in Zimbabwe and to determine factors associated with MTCT and maternal antiretroviral therapy (ART) or antiretroviral (ARV) prophylaxis. DESIGN: Analysis of cross-sectional data from mother-infant pairs. METHODS: We analyzed baseline data collected in 2012 as part of the impact evaluation of Zimbabwe's Accelerated National PMTCT Program. Using multistage cluster sampling, eligible mother-infant pairs were randomly sampled from the catchment areas of 157 facilities in 5 provinces, tested for HIV infection, and interviewed about PMTCT service utilization. RESULTS: Of 8800 women, 94% attended ≥ 1 antenatal care visit, 92% knew their HIV serostatus during pregnancy, 77% delivered in a health facility, and 92% attended the 6-8 week postnatal visit. Among 1075 (12%) HIV-infected women, 59% reported ART/ARV prophylaxis and 63% of their HIV-exposed infants received ARV prophylaxis. Among HIV-exposed infants, maternal receipt of ART/ARV prophylaxis was protective against MTCT [adjusted prevalence ratio (PR(a)): 0.41, 95% confidence interval (CI): 0.23 to 0.74]. Factors associated with receipt of maternal ART/ARV prophylaxis included ≥ 4 antenatal care visits (PR(a): 1.18, 95% CI: 1.01 to 1.38), institutional delivery (PR(a): 1.31, 95% CI: 1.13 to 1.52), and disclosure of serostatus (PRa: 1.30, 95% CI: 1.12 to 1.49). CONCLUSIONS: These data from women in the community indicate gaps in the PMTCT cascade before the accelerated program, which may have been missed by examination of health facility data alone. These gaps were especially noteworthy for services targeted specifically to HIV-infected women and their infants, such as maternal and infant ART/ARV prophylaxis.

Food insecurity is a barrier to prevention of mother-to-child HIV transmission services in Zimbabwe: a cross-sectional study.

BACKGROUND: Food insecurity (FI) is the lack of physical, social, and economic access to sufficient food for dietary needs and food preferences. We examined the association between FI and women's uptake of services to prevent mother-to-child HIV transmission (MTCT) in Zimbabwe. METHODS: We analyzed cross-sectional data collected in 2012 from women living in five of ten provinces. Eligible women were ≥16 years old, biological mothers of infants born 9-18 months before the interview, and were randomly selected using multi-stage cluster sampling. Women and infants were tested for HIV and interviewed about health service utilization during pregnancy, delivery, and post-partum. We assessed FI in the past four weeks using a subset of questions from the Household Food Insecurity Access Scale and classified women as living in food secure, moderately food insecure, or severely food insecure households. RESULTS: The weighted population included 8,790 women. Completion of all key steps in the PMTCT cascade was reported by 49%, 45%, and 38% of women in food secure, moderately food insecure, and severely food insecure households, respectively (adjusted prevalence ratio (PRa) = 0.95, 95% confidence interval (CI): 0.90, 1.00 (moderate FI vs. food secure), PRa = 0.86, 95% CI: 0.79, 0.94 (severe FI vs. food secure)). Food insecurity was not associated with maternal or infant receipt of ART/ARV prophylaxis. However, in the unadjusted analysis, among HIV-exposed infants, 13.3% of those born to women who reported severe household food insecurity were HIV-infected compared to 8.2% of infants whose mothers reported food secure households (PR = 1.62, 95% CI: 1.04, 2.52). After adjustment for covariates, this association was attenuated (PRa = 1.42, 95% CI: 0.89, 2.26). There was no association between moderate food insecurity and MTCT in unadjusted or adjusted analyses (PRa = 0.68, 95% CI: 0.43, 1.08). CONCLUSIONS: Among women with a recent birth, food insecurity is inversely associated with service utilization in the PMTCT cascade and severe household food insecurity may be positively associated with MTCT. These preliminary findings support the assessment of FI in antenatal care and integrated food and nutrition programs for pregnant women to improve maternal and child health.

Hormonal contraceptive use and women's risk of HIV acquisition: a meta-analysis of observational studies.

BACKGROUND: The evidence from epidemiological research into whether use of hormonal contraception increases women's risk of HIV acquisition is inconsistent. We did a robust meta-analysis of existing data to provide summary estimates by hormonal contraceptive method which can be used to inform contraceptive guidelines, models, and future studies. METHODS: We updated a recent systematic review to identify and describe studies that met inclusion criteria. To ensure inclusion of more recent research, we searched PubMed for articles published after December, 2011, using the terms "hormonal contraception", "HIV/acquisition", "injectables", "progestin", and "oral contraceptive pills". We assessed statistical heterogeneity for these studies, and, when appropriate, combined point estimates by hormonal contraception formulation using random-effects models. We assessed publication bias and investigated heterogeneity through subgroup and stratified analyses according to study population and design features. FINDINGS: We identified 26 studies, 12 of which met inclusion criteria. There was evidence of an increase in HIV risk in the ten studies of depot medroxyprogesterone acetate (pooled hazard ratio [HR] 1·40, 95% CI 1·16-1·69). This risk was lower in the eight studies done in women in the general population (pooled HR 1·31, 95% CI 1·10-1·57). There was substantial between-study heterogeneity in secondary analyses of trials (n=7, I(2) 51·1%, 95% CI 0-79·3). Although individual study estimates suggested an increased risk, substantial heterogeneity between two studies done in women at high risk of HIV infection (I(2) 54%, 0-88·7) precluded pooling estimates. There was no evidence of an increased HIV risk in ten studies of oral contraceptive pills (pooled HR 1·00, 0·86-1·16) or five studies of norethisterone enanthate (pooled HR 1·10, 0·88-1·37). INTERPRETATION: Our findings show a moderate increased risk of HIV acquisition for all women using depot medroxyprogesterone acetate, with a smaller increase in risk for women in the general population. Whether the risks of HIV observed in our study would merit complete withdrawal of depot medroxyprogesterone acetate needs to be balanced against the known benefits of a highly effective contraceptive. FUNDING: None.

Social network recruitment for Yo Puedo: an innovative sexual health intervention in an underserved urban neighborhood­sample and design implications.

Most existing evidence-based sexual health interventions focus on individual-level behavior, even though there is substantial evidence that highlights the influential role of social environments in shaping adolescents' behaviors and reproductive health outcomes. We developed Yo Puedo, a combined conditional cash transfer and life skills intervention for youth to promote educational attainment, job training, and reproductive health wellness that we then evaluated for feasibility among 162 youth aged 16-21 years in a predominantly Latino community in San Francisco, CA. The intervention targeted youth's social networks and involved recruitment and randomization of small social network clusters. In this paper we describe the design of the feasibility study and report participants' baseline characteristics. Furthermore, we examined the sample and design implications of recruiting social network clusters as the unit of randomization. Baseline data provide evidence that we successfully enrolled high risk youth using a social network recruitment approach in community and school-based settings. Nearly all participants (95%) were high risk for adverse educational and reproductive health outcomes based on multiple measures of low socioeconomic status (81%) and/or reported high risk behaviors (e.g., gang affiliation, past pregnancy, recent unprotected sex, frequent substance use; 62%). We achieved variability in the study sample through heterogeneity in recruitment of the index participants, whereas the individuals within the small social networks of close friends demonstrated substantial homogeneity across sociodemographic and risk profile characteristics. Social networks recruitment was feasible and yielded a sample of high risk youth willing to enroll in a randomized study to evaluate a novel sexual health intervention.

The SHAZ! project: results from a pilot randomized trial of a structural intervention to prevent HIV among adolescent women in Zimbabwe.

UNLABELLED: Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ!) was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control). The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83)], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62)] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01)], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the intervention model, and test the impact of the intervention at scale on biological outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02034214.

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

BACKGROUND: Prevention 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. METHODS: We 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. RESULTS: Of 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. CONCLUSIONS: Unmet 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.

Are hormonal contraceptive users more likely to misreport unprotected sex? Evidence from a biomarker validation study in Zimbabwe.

We analyzed biomarker validation data of unprotected sex from women in Zimbabwe to determine whether condom and sexual behavior misreporting differs between users of different contraceptive methods. Self-reported sexual behavior was compared with the presence of prostate-specific antigen (PSA) in vaginal fluid, a biomarker of semen exposure. Of the 195 women who were PSA positive, 94 (48 %) reported no sex or only condom-protected sex. Hormonal contraceptive users misreported sexual behavior less than women using non-hormonal methods (45 vs. 67 %, P = 0.03). This misclassification pattern could have implications on the elevated risk of HIV infection associated with hormonal contraception in some studies.

Yo Puedo--a conditional cash transfer and life skills intervention to promote adolescent sexual health: results of a randomized feasibility study in san francisco.

PURPOSE: We designed and evaluated for feasibility an intervention-Yo Puedo-that addresses social network influences and socioeconomic opportunities in a neighborhood with substantial gang exposure and early childbearing. METHODS: Yo Puedo combined conditional cash transfers for completion of educational and reproductive health wellness goals with life skills sessions, and targeted youth 16-21 years of age and same-aged members of their social network. We conducted a two-arm study with social networks randomized to the intervention or a standard services control arm. We evaluated intervention uptake, adherence, and safety; and assessed evidence of effects on behavioral outcomes associated with unintended pregnancy and sexually transmitted infection risk. RESULTS: A total of 72 social networks composed of 162 youth enrolled, with 92% retention over 6 months. Seventy-two percent of youth randomized to the intervention participated in intervention activities: 53% received at least one conditional cash transfer payment and 66% came to at least one life skills session. We found no evidence that cash payments financed illicit or high-risk behavior. At 6 months, compared with controls, intervention participants had a lower odds of hanging out on the street frequently (odds ratio [OR], .54; p = .10) and a lower odds of reporting that their close friends had been incarcerated (OR, .6; p = .12). They reported less regular alcohol use (OR, .54; p = .04) and a lower odds of having sex (OR, .50; p = .04). CONCLUSIONS: The feasibility evaluation of Yo Puedo demonstrated its promise; a larger evaluation of effects on pregnancy and sustained behavioral changes is warranted.

Food insecurity, socioeconomic status, and HIV-related risk behavior among women in farming households in Tanzania.

Food insecurity (FI) is associated with higher-risk sexual behavior in some studies. However, the overlap between FI and socioeconomic status (SES) has been poorly described. The study objectives were to: (1) determine the relationship between household FI and four dimensions of SES among sexually active Tanzanian women in farming households: expenditures, assets, flooring material of the home, and land ownership; and (2) determine whether FI is associated with higher-risk sexual behavior and relationship power. In male-headed households, FI was associated with assets, flooring material, and land ownership but not expenditures. There was no association between FI and the four dimensions of SES in female-headed households. Among women in male-headed households, but not female household heads themselves, severe FI was associated with a non-significant increase in the likelihood of being in a relationship because of material goods [adjusted prevalence ratio (PRa) = 1.76, 95 % confidence interval (CI) 0.81, 3.81] and was inversely associated with being able to ask partners to use condoms (PRa = 0.47, 95 % CI 0.25, 0.88). There was not a strong association between food security and relationship power. Our findings suggest that the association between FI and HIV risk behavior may differ depending on the type of household.