An HIV vaccine, once it becomes available, could reduce vulnerability to HIV among African-American women. The purpose of this study was to assess determinants of HIV vaccine acceptability among African-American women across hypothetical levels of vaccine efficacy. Participants were recruited from a hospital-based family planning clinic in Atlanta, GA serving low-income patients (N = 321). Data were collected from audio-computer assisted surveys administered in the clinic waiting room. Psychosocial survey items were guided by Risk Homeostasis Theory (RHT) and Social Cognitive Theory (SCT). Multivariate logistic regression was used to identify determinants of acceptability for two hypothetical HIV vaccines with 50% and 90% efficacy. Overall, 63% of participants would accept a vaccine with 50% efficacy and 85% would accept a vaccine with 90% efficacy. In multivariate analyses, odds of acceptability for a vaccine with 50% efficacy were higher among participants with greater perceived HIV vaccine benefits (AOR = 1.13, p < 0.001) and lower among participants with more than high school education (AOR = 0.47, p = 0.033) and greater perceived costs of HIV vaccination (AOR = 0.95, p = 0.010). Odds of acceptability for a vaccine with 90% efficacy were higher among participants with greater perceived costs of unprotected sex (AOR = 1.08, p = 0.026), HIV vaccine benefits (AOR = 1.23, p < 0.001) and self-efficacy for sex refusal (AOR = 1.11, p = 0.044). HIV vaccine acceptability was high, particularly for a vaccine with 90% efficacy. Findings suggest that demographic and psychosocial factors may impact acceptability of an eventual HIV vaccine. Once an HIV vaccine is available, interventions to maximize uptake may benefit from using RHT and SCT constructs to target relevant psychosocial factors, such as perceived benefits and perceived costs of vaccination.

Background: Programs for integration of family planning into HIV care must recognize current practices and desires among clients to appropriately target and tailor interventions. We sought to evaluate fertility intentions, unintended pregnancy, contraceptive and condom use among a cohort of HIV-infected women seeking family planning services within an antiretroviral therapy (ART) clinic. Methods: 200 women completed an interviewer-administered questionnaire during enrollment into a prospective contraceptive study at the Lighthouse Clinic, an HIV/ART clinic in Lilongwe, Malawi, between August and December 2010. Results: Most women (95%) did not desire future pregnancy. Prior reported unintended pregnancy rates were high (69% unplanned and 61% unhappy with timing of last pregnancy). Condom use was inconsistent, even among couples with discordant HIV status, with lack of use often attributed to partner's refusal. Higher education, older age, lower parity and having an HIV negative partner were factors associated with consistent condom usage. Discussion: High rates of unintended pregnancy among these women underscore the need for integ rating family planning, sexually transmitted infection (STI) prevention, and HIV services. Contraceptive access and use, including condoms, must be improved with specific efforts to enlist partner support. Messages regarding the importance of condom usage in conjunction with more effective modern contraceptive methods for both infection and pregnancy prevention must continue to be reinforced over the course of ongoing ART treatment.

Introduction: Postpartum family planning (PPFP) is critical to reduce maternal-child mortality, abortion and unintended pregnancy. As in most countries, the majority of PP women in Rwanda have an unmet need for PPFP. In particular, increasing use of the highly effective PP long-acting reversible contraceptive (LARC) methods (the intrauterine device (IUD) and implant) is a national priority. We developed a multilevel intervention to increase supply and demand for PPFP services in Kigali, Rwanda. Methods: We implemented our intervention (which included PPFP promotional counselling for clients, training for providers, and Ministry of Health stakeholder involvement) in six government health facilities from August 2017 to October 2018. While increasing knowledge and uptake of the IUD was a primary objective, all contraceptive method options were discussed and made available. Here, we report a secondary analysis of PP implant uptake and present already published data on PPIUD uptake for reference. Results: Over a 15-month implementation period, 12 068 women received PPFP educational counselling and delivered at a study facility. Of these women, 1252 chose a PP implant (10.4% uptake) and 3372 chose a PPIUD (27.9% uptake). On average providers at our intervention facilities inserted 83.5 PP implants/month and 224.8 PPIUDs/month. Prior to our intervention, 30 PP implants/month and 8 PPIUDs/month were inserted at our selected facilities. Providers reported high ease of LARC insertion, and clients reported minimal insertion anxiety and pain. Conclusions: PP implant and PPIUD uptake significantly increased after implementation of our multilevel intervention. PPFP methods were well received by clients and providers.

Objective: To examine bacterial vaginosis as an effect modifier for the association between hormonal contraception and incident HIV infection. Design: Serodiscordant couples enrolled in an open longitudinal cohort in Lusaka, Zambia from 1994 to 2012. This analysis was restricted to couples with an HIV-positive man enrolled between1994 and 2002 when a quarterly genital tract examination and HIV testing was performed. Methods: Multivariate Cox models evaluated the association between contraceptive method and HIV-acquisition, stratified by time-varying bacterial vaginosis status. Results: Among 564 couples contributing 1137.2 couple-years of observation, bacterial vaginosis was detected at 15.5% of study visits. Twenty-two of 106 seroconversions occurred during intervals after bacterial vaginosis was detected [12 on no method/nonhormonal method (nonhormonal contraception), two on injectables, eight on oral contraceptive pills (OCPs)]. Unadjusted seroincidence rates per 100 couple-years for nonhormonal contraception, injectable, and OCP users, respectively, during intervals with bacterial vaginosis were 8.3, 20.8, and 31.0 and during intervals without bacterial vaginosis were 8.2, 9.7, and 12.3. In the bacterial vaginosis-positive model, there was a significant increase in incident HIV among those using injectables (adjusted hazard ratio, aHR 6.55, 95% CI 1.14-37.77) and OCPs (aHR 5.20, 95% CI 1.68-16.06) compared with nonhormonal contraception. Hormonal contraception did not increase the hazard of HIV acquisition in bacterial vaginosis-negativ e models. These findings persisted in sensitivity analyses whenever all covariates from the nonstratified model previously published were included, whenever other genital tract findings were excluded from the model and with the addition of condom-less sex and sperm on wet-prep. Conclusion: Future research should consider a potential interaction with bacterial vaginosis whenever evaluating the impact of hormonal contraception on HIV acquisition.

Background: Studies have demonstrated the role of ulcerative and non-ulcerative sexually transmitted infections (STI) in HIV transmission/acquisition risk; less is understood about the role of non-specific inflammatory genital abnormalities. Methods: HIV-discordant heterosexual Zambian couples were enrolled into longitudinal follow-up (1994-2012). Multivariable models estimated the effect of genital ulcers and inflammation in both partners on time-to-HIV transmission within the couple. Population-attributable fractions (PAFs) were calculated. Results: A total of 207 linked infections in women occurred over 2756 couple-years (7.5/100 CY) and 171 in men over 3216 CY (5.3/100 CY). Incident HIV among women was associated with a woman's non-STI genital inflammation (adjusted hazard ratio (aHR) = 1.55; PAF = 8%), bilateral inguinal adenopathy (BIA; aHR = 2.33; PAF = 8%), genital ulceration (aHR = 2.08; PAF = 7%) and the man's STI genital inflammation (aHR = 3.33; PAF = 5%), BIA (aHR = 3.35; PAF = 33%) and genital ulceration (aHR = 1.49; PAF = 9%). Infection among men was associated with a man's BIA (aHR = 4.11; PAF = 22%) and genital ulceration (aHR = 3.44; PAF = 15%) as well as with the woman's non-STI genital inflammation (aHR = 1.92; PAF = 13%) and BIA (aHR = 2.76; PAF = 14%). In HIV-M+F- couples, the man being uncircumcised. with foreskin smegma. was associated with the woman's seroconversion (aHR = 3.16) relative to being circumcised. In F+M- couples, uncircumcised men with BIA had an increased hazard of seroconversion (aHR = 13.03 with smegma and 4.95 without) relative to being circumcised. Self-reporting of symptoms was low for ulcerative and non-ulcerative STIs. Conclusions: Our findings confirm the role of STIs and highlight the contribution of non-specific genital inflammation to both male-to-female and female-to-male HIV transmission/acquisition risk. Studies are needed to characterize pathogenesis of non-specific inflammation including inguinal adenopathy. A better understanding of genital practices could inform interventions.

Background: Since the Zika virus epidemic in the Americas began in 2015, Zika virus transmission has occurred throughout the Americas. However, limited information exists regarding possible risks of transmission of Zika virus and other flaviviruses through breast feeding and human milk. We conducted a systematic review of the evidence regarding flaviviruses detection in and transmission through milk, specifically regarding Zika virus, Japanese encephalitis virus, tick-borne encephalitis virus, Powassan virus, West Nile virus, dengue virus, and yellow fever virus. Methods: Medline, Embase, Global Health, CINAHL, Cochrane Library, Scopus, Popline, Virtual Health Library, and WorldCat were searched through June 2017. Two authors independently screened potential studies for inclusion and extracted data. Human and nonhuman (animal) studies describing: 1) confirmed or suspected cases of mother-to-child transmission through milk; or 2) the presence of flavivirus genomic material in milk. Results: Seventeen studies were included, four animal models and thirteen observational studies. Dengue virus, West Nile virus, and Zika virus viral ribonucleic acid was detected in human milk, including infectious Zika virus and dengue virus viral particles. Human breast-feeding transmission was confirmed for only yellow fever virus. There was evidence of milk-related transmission of dengue virus, Powassan virus, and West Nile virus in animal studies. Conclusions: Because the health advantages of breast feeding are considered greater than the potential risk of transmission, the World Health Organization recommends that mothers with possible or confirmed Zika virus infection or exposure continue to breast feed. This review did not identify any data that might alter this recommendation.

Background: Understanding the factors associated with the use of hormonal and intrauterine contraception among HIV-infected men and women may lead to interventions that can help reduce high unintended pregnancy rates. Materials and Methods: This study is a subanalysis of a cross-sectional survey of 289 women and 241 men who were sexually active and HIV-infected and were attending HIV care visits in Lilongwe, Malawi. We estimated adjusted prevalence ratios (PRs) to evaluate factors associated with hormonal and intrauterine contraceptive use for men and women in separate models. Results and Discussion: 39.8% of women and 33.2% of men (p = 0.117) reported that they were using hormonal or intrauterine contraception at last intercourse. Having greater than 3 children was the only factor associated with hormonal and intrauterine contraceptive use among men. Among women, younger age, not wanting a pregnancy in 2 years, being with their partner for more than 4 years, and being able to make family planning decisions by themselves were associated with hormonal and intrauterine contraceptive use. Conclusions: The men and women in our study population differed in the factors associated with hormonal and intrauterine contraceptive use. Understanding these differences may help decrease unmet FP needs among HIV-infected men and women.

BACKGROUND:: Understanding associations between pregnancy and HIV disease progression is critical to providing appropriate counseling and care to HIV-positive women. METHODS:: From 2006-2011, women under age 40 with incident HIV infection were enrolled in an early HIV infection cohort in Kenya, Rwanda, South Africa, Uganda, and Zambia. Time-dependent Cox models evaluated associations between pregnancy and HIV disease progression. Clinical progression was defined as a single CD4 measurement <200 cells/μL, percent CD4 <14%, or category C event, with censoring at antiretroviral (ART) initiation for reasons other than prevention of mother-to-child transmission (PMTCT). Immunologic progression was defined as two consecutive CD4s ≤350 cells/μL or a single CD4 ≤350 cells/μL followed by non-PMTCT ART initiation. Generalized estimating equations assessed changes in CD4 before and after pregnancy. RESULTS:: Among 222 women, 63 experienced clinical progression during 783.5 person-years at-risk (8.0/100). Among 205 women, 87 experienced immunologic progression during 680.1 person-years at risk (12.8/100). The association between pregnancy and clinical progression was adjusted hazard ratio [aHR]=0.7;95%CI:0.2-1.8. The association between pregnancy and immunologic progression was aHR=1.7;95%CI:0.9-3.3. Models controlled for age; human leukocyte antigen alleles A*03:01, B*45, B*57; CD4 set point; and HIV-1 subtype. CD4 measurements before versus after pregnancies were not different. CONCLUSIONS:: In this cohort, pregnancy was not associated with increased clinical or immunologic HIV progression. Similarly, we did not observe meaningful deleterious associations of pregnancy with CD4s. Our findings suggest that HIV-positive women may become pregnant without harmful health effects occurring during the pregnancy. Evaluation of longer-term impact of pregnancy on progression is warranted.

Background While prior epidemiologic studies have suggested that injectable progestin-based contraceptive depot medroxyprogesterone acetate (DMPA) use may increase a woman’s risk of acquiring HIV, recent data have suggested that DMPA users may be at a similar risk for HIV acquisition as users of the copper intrauterine device and levonorgestrel implant. Use of the etonogestrel Implant (Eng-Implant) is increasing but there are currently no studies evaluating its effect on HIV acquisition risk. Objective Evaluate the potential effect of the Eng-Implant use on HIV acquisition risk by analyzing HIV target cells and cytokine profiles in the lower genital tract and blood of adult premenopausal HIV-negative women using the Eng-Implant. Methods We prospectively obtained paired cervicovaginal lavage (CVL) and blood samples at 4 study visits over 16 weeks from women between ages 18–45, with normal menses (22–35 day intervals), HIV uninfected with no recent hormonal contraceptive or copper intrauterine device (IUD) use, no clinical signs of a sexually transmitted infection at enrollment and who were medically eligible to initiate Eng-Implant. Participants attended pre-Eng-Implant study visits (week -2, week 0) with the Eng-Implant inserted at the end of the week 0 study visit and returned for study visits at weeks 12 and 14. Genital tract leukocytes (enriched from CVL) and peripheral blood mononuclear cells (PBMC) from the study visits were evaluated for markers of activation (CD38, HLA-DR), retention (CD103) and trafficking (CCR7) on HIV target cells (CCR5+CD4+ T cells) using multicolor flow cytometry. Cytokines and chemokines in the CVL supernatant and blood plasma were measured in a Luminex assay. We estimated and compared study endpoints among the samples collected before and after contraception initiation with repeated-measures analyses using linear mixed models. Results Fifteen of 18 women who received an Eng-Implant completed all 4 study visits. The percentage of CD4+ T cells in CVL was not increased after implant placement but the percentage of CD4+ T cells expressing the HIV co-receptor CCR5 did increase after implant placement (p = 0.02). In addition, the percentage of central memory CD4+ T-cells (CCR7+) in CVL increased after implant placement (p = 0.004). The percentage of CVL CD4+, CCR5+ HIV target cells expressing activation markers after implant placement was either reduced (HLADR+, p = 0.01) or unchanged (CD38+, p = 0.45). Most CVL cytokine and chemokine concentrations were not significantly different after implant placement except for a higher level of the soluble lymphocyte activation marker (sCD40L; p = 0.04) and lower levels of IL12p70 (p = 0.02) and G-CSF (p<0.001). In systemic blood, none of the changes noted in CVL after implant placement occurred except for decreases in the percentage CD4 T-cells expressing HLA-DR+ T cells (p = 0.006) and G-CSF (p = 0.02). Conclusions Eng-Implant use was associated with a moderate increase in the availability of HIV target cells in the genital tract, however the percentage of these cells that were activated did not increase and there were minimal shifts in the overall immune environment. Given the mixed nature of these findings, it is unclear if these implant-induced changes alter HIV risk.

Background: Black adolescent and young adult women (AYAW) in the Southern United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to health services that AYAW already trust, access routinely, and deem useful for their sexual health may offer an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. These services include those of family planning (FP) providers in high HIV incidence settings. However, PrEP has not been widely integrated into FP services, including Title X-funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies. Objective: The aim of this study is to assess inner and outer context factors (barriers and facilitators) that may influence the adoption of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern United States. Methods: Phase 1 of Planning4PrEP is an explanatory sequential, mixed methods study consisting of a geographically-targeted Web-based survey of Title X clinic administrators and providers in the Southern United States, followed by key informant interviews among a purposively selected subset of responders to more comprehensively assess inner and outer context factors that may influence adoption and implementation of PrEP in Title X FP clinics in the South. Results: Phase 1 of Planning4PrEP research activities began in October 2017 and are ongoing. To date, survey and key informant interview administration is near completion, with quantitative and qualitative data analysis scheduled to begin soon after data collection completion. Conclusions: This study seeks to assess inner and outer contextual factors (barriers and facilitators) that may influence the adoption and integration of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern United States. Data gained from this study will inform a type 1 hybrid effectiveness implementation study, which will evaluate the multilevel factors associated with successful PrEP implementation while evaluating the degree of PrEP uptake, continuation, and adherence among women seen in Title X clinics.