Monitoring of Adverse Events in Recipients of the 2-Dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in the UMURINZI Ebola Vaccination Campaign.

BACKGROUND: From 2019 to 2021, Rwandan residents of the border with the Democratic Republic of the Congo were offered the Ad26.ZEBOV (adenovirus type 26 vector vaccine encoding Ebola virus glycoprotein) and MVA-BN-Filo (modified vaccinia virus Ankara vector vaccine, encoding glycoproteins from Ebola, Sudan, Marburg, and nucleoprotein from Tai Forest viruses) Ebola vaccine regimen. METHODS: Nonpregnant persons aged ≥2 years were eligible. Unsolicited adverse events (UAEs) were reported through phone calls or visits, and serious adverse events (SAEs) were recorded per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. RESULTS: Following Ad26.ZEBOV, UAEs were reported by 0.68% of 216 113 vaccinees and were more common in younger children (aged 2-8 years, 1.2%) compared with older children (aged 9-17 years, 0.4%) and adults (aged ≥18 years, 0.7%). Fever and headache were the most reported symptoms. All 17 SAEs related to vaccine were in children aged 2-8 years (10 postvaccination febrile convulsions ± gastroenteritis and 7 fever and/or gastroenteritis). The incidence of febrile seizures was 8 of 26 062 (0.031%) prior to initiation of routine acetaminophen in December 2020 and 2 of 15 897 (0.013%) thereafter. Nonobstetric SAEs were similar in males and females. All 20 deaths were unrelated to vaccination. Young girls and adult women with UAEs were less likely to receive the second dose than those without UAEs. Seven unrelated SAEs occurred in 203 267 MVA-BN-Filo recipients. CONCLUSIONS: Postvaccination febrile convulsions in young children were rare but not previously described after Ad26.ZEBOV and were reduced with routine acetaminophen. The regimen was otherwise safe and well-tolerated.

A Relationship-Focused HIV Prevention Intervention for Young Sexual Minority Men in the United States: A Pilot Randomized Controlled Trial of the We Prevent Intervention.

We Prevent is a virtual counseling intervention designed to improve communication as a mechanism for reducing HIV risk among young sexual minority men (SMM) in relationships. We evaluated the feasibility, acceptability, and preliminary efficacy of We Prevent in comparison to standard Counseling, Testing, and Referral among a national sample of 318 SMM ages 15-24 in a pilot randomized control trial. We found significant differences in condomless sex with outside partners; however, there were no differences in other sexual behaviors, sexual agreements, intimate partner violence (IPV), or communication between the conditions across the 9-month follow-ups. Stratified analyses found non-significant trends suggestive that We Prevent may reduce condomless sex for those ages 15-17 and for relationships over 1-year and may reduce IPV in relationships over 1-year. Though study retention was adequate, session attendance was low. Exit interviews participants reported benefits of We Prevent and provided insights into how to increase uptake.

Use of "Strengthening Our Vows" Video Intervention to Encourage Negotiated Explicit Sexual Agreements in Zambian Heterosexual HIV Seroconcordant-Negative Couples.

Negotiating sexual agreements in combination with couples' voluntary HIV counseling and testing (CVCT) may help further reduce HIV transmission in Zambian concordant HIV-negative couples (CNC). Though CVCT has been shown to reduce HIV transmission in CNC by 47%, approximately half of residual infections occur in this group. We developed a "Strengthening Our Vows" video session to foster communication and negotiation of explicit sexual agreements to reduce concurrent sexual exposures and prevent HIV transmission to the spouse due to unprotected, extramarital sex. CNC were recruited through CVCT services at five clinics in Lusaka and Ndola in 2016. Enrolled CNC attending the facilitated group video sessions were encouraged to discuss sexual agreements at home and return 1-2 weeks later for follow-up assessment. One-fourth of the 580 CNC returning reported a history of extramarital partners and/or a sexually transmitted infection (STI) prior to enrollment. More than 95% reported a friendly, supportive 15-60 min negotiation culminating in an agreement to remain monogamous or disclose sexual contacts and use condoms together until a repeat HIV test 30 days after an outside sexual exposure. Two-thirds of participants identified at least one threat to adherence of their agreements including alcohol use, financial pressures, travel, discord in the home, and post-partum or menstrual abstinence. CNC negotiated explicit sexual agreements to avoid exposure to HIV through concurrent partnerships and protect the spouse in the event of an outside sexual contact. Open communication was a consistent theme to facilitate mutual protective efforts. Long-term follow-up of HIV/STI incidence is ongoing to assess the impact of these agreements.Trial registration This sub-study is part of a trial retrospectively registered on ClinicalTrials.gov (Identifier: NCT02744586) on April 20, 2016.

Factors Associated With Anal High-Grade Intraepithelial Lesions and Carcinoma Among Young Men Who Have Sex With Men and Transgender Women With HIV in Atlanta.

OBJECTIVE: This study aimed to evaluate factors associated with anal high-grade intraepithelial lesions (HSIL) and anal carcinoma among young men who have sex with men (MSM) and transgender women (TW) with HIV in Atlanta, GA, to better inform screening guidelines and preventative measures. MATERIALS AND METHODS: Cross-sectional retrospective chart review was completed for cisgender MSM and TW with HIV aged 13-25 years at the Grady Ponce and Family Youth Clinic in Atlanta, GA, from 2009 to 2020. High-grade anal disease was defined as anal intraepithelial neoplasia (AIN) 2, 3, or anal carcinoma (AIN 2+). Associations between clinical and demographic factors with AIN 2+ were estimated using logistic regression. Adjusted odds ratios (aORs) and associated 90% CIs are reported. RESULTS: One hundred nine MSM and TW with HIV who underwent anoscopy were included. One hundred three participants received anal biopsies, and 62% had AIN 2+. Being incompletely or unvaccinated against human papillomavirus (HPV, 0-2 doses) relative to being fully vaccinated (3 doses; aOR = 5.85; 90% CI = 1.28-26.83; p = .06) and having ever received surgical treatment for anogenital HPV (aOR = 2.89; 90% CI = 1.10-7.65; p = .07) were associated with AIN 2+, controlling for age and CD4 T-cell count at time of biopsy. CONCLUSIONS: Our study found a high prevalence of anal HSIL among young MSM and TW with HIV. Those who had ever received surgical treatment for anogenital HPV and those who were incompletely or unvaccinated against HPV were more likely to have HSIL. Our data emphasize the urgent need to improve HPV vaccination efforts and to pursue larger surveillance studies of anal HSIL and carcinoma among young MSM and TW with HIV.

Trichomonas vaginalis and Spontaneous Preterm Birth in a High-Risk Obstetric Cohort in Atlanta, GA.

BACKGROUND: Trichomonas vaginalis (TV) is the most prevalent nonviral sexually transmitted infection globally, but routine screening is not recommended in HIV-negative individuals. There is a significant racial/ethnic health disparity in TV infection rates. Evidence regarding the association between TV and adverse perinatal outcomes is conflicting, but a recent large meta-analysis found a modest increased risk of preterm birth with TV infection (odds ratio, 1.27; 95% confidence interval, 1.08-1.50). The current study was undertaken to evaluate whether TV infection increases the risk of spontaneous preterm birth (sPTB) in a high-risk obstetric cohort in Atlanta, GA. METHODS: We conducted a retrospective cohort study of women delivering at a safety-net hospital in Atlanta between July 2016 and June 2018. Women delivering a singleton live fetus at >20 weeks' gestation were included. The diagnosis of TV was by nucleic acid amplification testing. The outcome of interest was sPTB before 37 weeks' gestation. Multivariable Cox proportional hazards modeling was used to estimate the effect of TV on sPTB, controlling for confounding variables, including clinical and demographic characteristics. Several sensitivity analyses were undertaken. RESULTS: There were 3723 deliveries during the study period, and approximately half (46%) were screened for TV with nucleic acid amplification testing. After exclusions, the analytic cohort included 1629 women. Median age was 26 years (interquartile range, 22-31 years), and 70% of participants were listed as non-Hispanic Black in the electronic medical record. The prevalence of TV was 16% (n = 257). The sPTB rate was 7% (n = 112). In multivariable Cox proportional hazards modeling, TV infection was not associated with a statistically significantly increased risk of sPTB (hazard ratio, 1.34; 95% confidence interval, 0.84-2.13; P = 0.22). Factors associated with sPTB included history of PTB, adequate plus or transfer of prenatal care (vs. adequate/intermediate prenatal care utilization using the Kotelchuck index), recreational substance use, and Chlamydia trachomatis diagnosed during the current pregnancy. Results were not substantively different in sensitivity analyses. CONCLUSIONS: The prevalence of TV was high in this cohort. Its infection was not associated with a statistically significantly increased risk of sPTB. Nevertheless, the magnitude of effect is consistent with prior meta-analyses.

Interest in and Uptake of Postabortion Long-Acting Reversible Contraception After Counseling at a Free-Standing Abortion Care Ambulatory Surgery Center, Atlanta, Georgia, 2017‒2018.

We sought to determine the impact of brief previsit counseling on long-acting reversible contraception (LARC) interest and uptake immediately after abortion. We conducted a randomized controlled trial at a free-standing abortion care ambulatory surgery center in metro-Atlanta, Georgia (2017-2018). Among 1270 women, a brief previsit counseling intervention increased interest in LARC by 4.5 percentage points, and interest in LARC after the intervention increased uptake by 9.6 percentage points. Providing brief previsit counseling significantly increased postabortion LARC uptake. (Am J Public Health. 2022;112(9):1257-1260. https://doi.org/10.2105/AJPH.2022.306940).

Evolution of Condom Use Among a 5-Year Cohort of Female Sex Workers in Zambia.

Observing sexual behaviour change over time could help develop behavioural HIV prevention interventions for female sex workers in Zambia, where these interventions are lacking. We investigated the evolution of consistent condom use among female sex workers and their clients and steady partners. Participants were recruited into an HIV incidence cohort from 2012 to 2017. At each visit, women received HIV counselling and testing, screening for sexually transmitted infections (STIs) and free condoms. Our outcome was reported consistent (100%) condom use in the previous month with steady partners, repeat clients, and non-repeat clients. Consistent condom use at baseline was highest with non-repeat clients (36%) followed by repeat clients (27%) and steady partners (17%). Consistent condom use between baseline and Month 42 increased by 35% with steady partners, 39% with repeat clients and 41% with non-repeat clients. Access to condoms, HIV/STI counselling and testing promoted positive sexual behaviour change.

Genital Abnormalities, Hormonal Contraception, and Human Immunodeficiency Virus Transmission Risk in Rwandan Serodifferent Couples.

BACKGROUND: We explored the role of genital abnormalities and hormonal contraception in human immunodeficiency virus (HIV) transmission among heterosexual serodifferent couples in Rwanda. METHODS: From 2002 to 2011, HIV-serodifferent couples who were not using antiretroviral treatment were followed up, and sociodemographic and clinical data were collected, family planning provided, and HIV-negative partners retested. Couples were assessed for genital ulcers; nonulcerative genital sexually transmitted infection (STIs), including gonorrhea, chlamydia, and trichomoniasis; and non-STI vaginal infections, including bacterial vaginosis and candida. Multivariable models evaluated associations between covariates and HIV transmission genetically linked to the index partner. RESULTS: Among 877 couples in which the man was HIV positive, 37 linked transmissions occurred. Factors associated with women's HIV acquisition included genital ulceration in the female partner (adjusted hazard ratio, 14.1) and nonulcerative STI in the male partner (8.6). Among 955 couples in which the woman was HIV positive, 46 linked transmissions occurred. Factors associated with HIV acquisition in men included nonulcerative STI in the female partner (adjusted hazard ratio, 4.4), non-STI vaginal dysbiosis (7.1), and genital ulceration in the male partner (2.6). Hormonal contraception use was not associated with HIV transmission or acquisition. CONCLUSIONS: Our findings underscore the need for integrating HIV services with care for genital abnormalities. Barriers (eg, cost of training, demand creation, advocacy, and client education; provider time; and clinic space) to joint HIV/STI testing need to be considered and addressed.

Association of Delayed Treatment of Chlamydial Infection and Gonorrhea in Pregnancy and Preterm Birth.

BACKGROUND: Treating chlamydia and gonorrhea in pregnancy has been shown to decrease the associated risk of preterm birth in some studies. Delayed treatment of these infections among nonpregnant patients carries known consequences. It is unclear whether delayed treatment in pregnancy similarly increases adverse outcomes. METHODS: We conducted a retrospective cohort study of women who delivered at a safety-net hospital from July 2016 to June 2018. Women with at least one visit who were tested for chlamydia and gonorrhea were included. Women diagnosed after 36 weeks (preterm analysis) or 31 weeks (early preterm analysis) were excluded. We used multivariable logistic regression to examine the association between no infection, timely treatment (<1 week), and delayed treatment (>1 week, not treated) with preterm (<37 weeks) and early preterm (<32 weeks) birth. RESULTS: Among 3154 deliveries, 389 (12%) were preterm. Among 3107 deliveries, 74 (2%) were early preterm. In adjusted models, women with timely (adjusted odds ratio [aOR]; 1.7, 95% confidence interval [CI], 1.0-2.7) and delayed (aOR, 1.7; 95% CI, 1.1-2.5) treatments had increased odds of preterm birth. Similarly, women with timely (aOR, 2.5; 95% CI, 1.0-6.2) and delayed (aOR, 2.4; 95% CI, 1.2-4.9) treatments had increased odds of early preterm birth. Among women who tested positive, multiple infections were not associated with an increase in preterm birth (preterm: 17% vs. 20%, P = 0.53; early preterm: 5% vs. 6%, P = 0.74). CONCLUSIONS: Chlamydia and gonorrhea are associated with preterm and early preterm births, regardless of time to treatment. Creative solutions are needed to improve the prevention of these infections in pregnancy.

Antiretroviral Therapy Use and HIV Transmission Among Discordant Couples in Nonresearch Settings in Kigali, Rwanda.

BACKGROUND: Antiretroviral therapy (ART) efficacy for HIV prevention among discordant couples has been demonstrated in clinical trials. Effectiveness outside of research settings is less well understood. METHODS: HIV-discordant couples were enrolled in couples' testing and follow-up at 20 government clinics in Kigali from 2010 to 2014. We performed viral linkage analysis on seroconverting couples to determine infection sources (intracouple vs. extracouple). Antiretroviral therapy use in index partners was collected at baseline and during follow-up by self-report with verification of government medical records. RESULTS: A total of 3777 HIV-discordant couples were identified and followed up at government health clinics. Fifty-four incident HIV infections were identified, of which 36 were confirmed linked to the index partner, 4 were unlinked, and 14 were unknown. Among the 50 linked or unknown transmission pairs, 38% occurred among couples in which the index partner was on ART (HIV incidence rate of 0.63/100 person-years), whereas 62% occurred among couples in which the index partner was not on ART (HIV incidence rate of 5.51/100 person-years; adjusted rate ratio, 6.9). HIV acquisition was higher in women than in men with non-ART using index partners (P < 0.001). CONCLUSIONS: Couples in a government clinic couples' HIV testing and follow-up program in Rwanda had an 89% reduction in HIV incidence when index partners were using ART, slightly lower than efficacy estimates from randomized trials. Antiretroviral therapy for prevention should be prioritized for key populations including discordant couples identified via couples' voluntary counseling and testing, with increased efforts to improve uptake, adherence, and viral load monitoring.

Developing and validating a risk algorithm to diagnose Neisseria gonorrhoeae and Chlamydia trachomatis in symptomatic Rwandan women.

BACKGROUND: Algorithms that bridge the gap between syndromic sexually transmitted infection (STI) management and treatment based in realistic diagnostic options and local epidemiology are urgently needed across Africa. Our objective was to develop and validate a risk algorithm for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) diagnosis among symptomatic Rwandan women and to compare risk algorithm performance to the current Rwandan National Criteria for NG/CT diagnosis. METHODS: The risk algorithm was derived in a cohort (n = 468) comprised of symptomatic women in Kigali who sought free screening and treatment for sexually transmitted infections and vaginal dysbioses at our research site. We used logistic regression to derive a risk algorithm for prediction of NG/CT infection. Ten-fold cross-validation internally validated the risk algorithm. We applied the risk algorithm to an external validation cohort also comprised of symptomatic Rwandan women (n = 305). Measures of calibration, discrimination, and screening performance of our risk algorithm compared to the current Rwandan National Criteria are presented. RESULTS: The prevalence of NG/CT in the derivation cohort was 34.6%. The risk algorithm included: age < =25, having no/primary education, not having full-time employment, using condoms only sometimes, not reporting genital itching, testing negative for vaginal candida, and testing positive for bacterial vaginosis. The model was well calibrated (Hosmer-Lemeshow p = 0.831). Higher risk scores were significantly associated with increased prevalence of NG/CT infection (p < 0.001). Using a cut-point score of > = 5, the risk algorithm had a sensitivity of 81%, specificity of 54%, positive predictive value (PPV) of 48%, and negative predictive value (NPV) of 85%. Internal and external validation showed similar predictive ability of the risk algorithm, which outperformed the Rwandan National Criteria. Applying the Rwandan National Criteria cutoff of > = 2 (the current cutoff) to our derivation cohort had a sensitivity of 26%, specificity of 89%, PPV of 55%, and NPV of 69%. CONCLUSIONS: These data support use of a locally relevant, evidence-based risk algorithm to significantly reduce the number of untreated NG/CT cases in symptomatic Rwandan women. The risk algorithm could be a cost-effective way to target treatment to those at highest NG/CT risk. The algorithm could also aid in sexually transmitted infection risk and prevention communication between providers and clients.

Cross-sectional assessment of government health center needs to implement long-acting reversible contraception services in rural Rwanda.

BACKGROUND: There is unmet need for family planning in Rwanda. We previously developed an evidence-based couples' family planning counseling (C)FPC program in the capital city that combines: (1) fertility goal-based family planning counseling with a focus on long-acting reversible contraceptive (LARC) for couples wishing to delay pregnancy; (2) health center capacity building for provision of LARC methods, and (3) LARC promotion by community health workers (CHW) trained in community-based provision of oral and injectable contraception. From 2015 to 2016, this service was integrated into eight government health centers in Kigali, reaching 6072 clients and resulting in 5743 LARC insertions. METHODS: From May to July 2016, we conducted cross-sectional health center needs assessments in 30 rural health centers using surveys, key informant interviews, logbook extraction, and structured observations. The assessment focused on the infrastructure, materials, and human resources needed for LARC demand creation and provision. RESULTS: Few nurses had received training in LARC insertion [41% implant, 27% intrauterine device (IUD)]. All health centers reported working with CHW, but none trained in LARC promotion. Health centers had limited numbers of IUDs (median 10), implants (median 39), functional gynecological exam tables (median 2), and lamps for viewing the cervix (median 0). Many did not have backup power supplies (40%). Most health centers reported no funding partners for family planning assistance (60%). Per national guidelines, couples' voluntary HIV counseling and testing (CVCT) was provided at the first antenatal visit at all clinics, reaching over 80% of pregnant women and their partners. However, only 10% of health centers had integrated family planning and HIV services. CONCLUSIONS: To successfully implement (C)FPC and LARC services in rural health centers across Rwanda, material and human resource capacity for LARC provision will need to be greatly strengthened through equipment (gynecological exam tables, sterilization capacity, lamps, and backup power supplies), provider trainings and follow-up supervision, and new funding partnerships. Simultaneously, awareness of LARC methods will need to be increased among couples through education and promotion to ensure that demand and supply scale up together. The potential for integrating (C)FPC with ongoing CVCT in antenatal clinics is unique in Africa and should be pursued.

A Population-Specific Optimized GeneXpert Pooling Algorithm for Chlamydia trachomatis and Neisseria gonorrhoeae To Reduce Cost of Molecular Sexually Transmitted Infection Screening in Resource-Limited Settings.

The sexually transmitted infections (STIs) chlamydia (CT) and gonorrhea (NG) are often asymptomatic in women and undetected by syndromic management, leading to complications such as pelvic inflammatory disease, infertility, and ectopic pregnancy. Molecular testing, such as the GeneXpert CT/NG assay, is highly sensitive, but cost restraints preclude implementation of these technologies in resource-limited settings. Pooled testing is one strategy to reduce the cost per sample, but the extent of savings depends on disease prevalence. The current study describes a pooling strategy based on identification of sociodemographic and laboratory factors associated with CT/NG prevalence in a high-risk cohort of Zambian female sex workers and single mothers conducted from 2016 to 2019. Factors associated with testing positive for CT/NG via logistic regression modeling included city, younger age, lower education, long-acting reversible contraception usage, Trichomonas vaginalis infection, bacterial vaginosis, and incident syphilis infection. Based on these factors, the study population was stratified into high-, intermediate-, and low-prevalence subgroups and tested accordingly-individually, pools of 3, or pools of 4, respectively. The cost per sample was reduced from $18 to as low as $9.43 in the low-prevalence subgroup. The checklist tool and pooling approach described can be used in a variety of treatment algorithms to lower the cost per sample and increase access to molecular STI screening. This is particularly valuable in resource-limited settings to detect and treat asymptomatic CT/NG infections missed by traditional syndromic management.

Motivational interviewing to promote long-acting reversible contraception among Rwandan couples wishing to prevent or delay pregnancy.

BACKGROUND: Few family-planning programs in Africa base demand creation and service delivery on theoretical models. Motivational interviewing is a counseling modality that facilitates reflection on the benefits and disadvantages of a health outcome to encourage behavior change. OBJECTIVES: We evaluate a couples-focused joint family-planning and HIV counseling intervention using motivational interviewing to enhance uptake of long-acting reversible contraception (Paragard copper intrauterine device or Jadelle hormonal implant) among Rwandan couples. STUDY DESIGN: In this experimental study, couples receiving care at 8 government health clinics in Kigali, the capital city, were referred from a parent study of couples who did not want more children or wanted to wait at least 2 years for their next pregnancy. Long-acting reversible contraception methods were offered on site following joint HIV testing and family-planning counseling. At the first follow-up visit 1 month after enrollment in the parent study, couples who had not yet chosen a long-acting reversible contraception method were interviewed separately using motivational interviewing and then brought together and again offered long-acting reversible contraception. RESULTS: Following motivational interviewing, 78 of 229 couples (34%) requested a long-acting reversible contraception method (68 implant and 10 intrauterine device). Long-acting reversible contraception uptake after motivational interviewing was associated with the woman being Catholic (vs Protestant/Muslim/other, adjusted odds ratio, 2.87, 95% confidence interval, 1.19-6.96, P = .019) or having an income (vs no income, adjusted odds ratio, 2.54, 95% confidence interval, 1.12-5.73, P = .025); the couple having previously discussed long-acting reversible contraception (adjusted odds ratio, 8.38, 95% confidence interval, 2.54-27.59, P = .0005); either partner believing that unplanned pregnancy was likely with their current method (adjusted odds ratio, 6.67, 95% confidence interval, 2.77-16.11, P < .0001); or that they might forget to take or make an appointment for their current method (adjusted odds ratio, 4.04, 95% confidence interval, 1.32-12.34, P = .014). Neither partner mentioning that condoms also prevent HIV/sexually transmitted infection was associated with long-acting reversible contraception uptake (adjusted odds ratio, 2.86, 95% confidence interval, 1.17-7.03, P = .022), as was the woman citing long-term duration of action of the implant as an advantage (adjusted odds ratio, 5.41, 95% confidence interval, 1.86-15.76, P = .002). The woman not listing any side effects or disadvantages of implants was associated with long-acting reversible contraception uptake (adjusted odds ratio, 5.42, 95% confidence interval, 2.33-12.59, P < .0001). Clinic location (rural vs urban), couple HIV status, and concerns about negative economic effects of an unplanned pregnancy were significant in bivariate but not multivariate analysis. CONCLUSION: Encouraging couples to reflect on the benefits and disadvantages of long-acting reversible contraception methods, the likelihood of unplanned pregnancy with their current contraception, and the impact of an unplanned pregnancy is an effective motivational interviewing technique in family-planning counseling. One third of couples who did not want a pregnancy for at least 2 years but had not chosen a long-acting reversible contraception method when provided with standard family-planning counseling did so after motivational interviewing. Involving the male partner in family-planning discussions facilitates joint decision making about fertility goals and contraceptive choice. Combining family planning and joint HIV testing for couples allows targeted focus on dual-method use with discordant couples, who are advised to use condoms for HIV/sexually transmitted infection prevention along with a more effective contraceptive for added protection against unplanned pregnancy.

A couple-focused, integrated unplanned pregnancy and HIV prevention program in urban and rural Zambia.

BACKGROUND: Zambia's total fertility rate (5 births per woman) and adult HIV prevalence (11.5%) are among the highest in the world, with heterosexual couples being the most affected group. Jointly counseling and testing couples for HIV has reduced up to 58% of new HIV infections in Zambian clinics. Married women using contraceptives in Zambia have a high (20%) unmet need for family planning and low (8.6%) uptake of cost-effective long-acting reversible contraceptives. We present an integrated counseling, testing, and family-planning program to prevent HIV and unplanned pregnancy in Zambia. OBJECTIVE: The objective of this study was to integrate effective HIV prevention and family-planning services for Zambian couples. STUDY DESIGN: A 3 year program (2013-2016) progressively integrated the promotion and provision of couples' voluntary HIV counseling and testing and long-acting reversible contraceptives. The program was based in 55 urban and 215 rural government clinics across 33 districts. In the first year, a couples' family-planning counseling training program was developed and combined with existing couples HIV counseling training materials. To avoid congestion during routine clinic hours, joint counseling services were initially provided on weekends, while nurses were trained in intrauterine device and hormonal implant insertion and removal during weekday family-planning services. Demand was created through mutual referral between weekend and weekday programs and by clinic staff, community health workers, and satisfied family-planning clients. When the bulk of integrated service training was completed, the program transitioned services to routine weekday clinic hours, ensuring access to same-day services. Performance indicators included number of staff trained, clients served, integrated service referrals, HIV infections averted, and unplanned pregnancies averted. RESULTS: A stepwise approach trained high-performing service providers to be trainers and used high-volume clinics for practicum training of the next generation. In total, 1201 (391 urban, 810 rural) counselors were trained and served 120,535 urban and 87,676 rural couples. In urban clinics, 236 nurses inserted 65,619 long-acting reversible contraceptives, while in rural clinics, 243 nurses inserted 35,703 implants and intrauterine devices. The program prevented an estimated 12,869 urban and 8279 rural adult HIV infections, and 98,626 unintended urban pregnancies. In the final year, the proportion of clients receiving joint counseling services on weekdays rose from 11% to 89%, with many referred from within clinics including HIV testing and treatment services (32%), outpatient department (31%), family planning (16%), and infant vaccination (15%). The largest group of clients requesting long-acting reversible contraceptives (45%) did so after joint fertility goal-based counseling, confirming the high impact of this couple-focused demand creation approach. Remaining family-planning clients responded to referrals from clinic nurses (34%), satisfied implant/intrauterine device users (13%), or community health workers (8%). CONCLUSION: Integrated HIV and unplanned pregnancy prevention can be implemented in low-resource public sector facilities. Combination services offered to couples mutually leverage HIV prevention and unplanned pregnancy prevention. The addition of long-acting reversible contraceptives is an important complement to the method mix available in government clinics. Demand creation in the clinic and in the community must be coordinated with a growing supply of well-trained providers.

Fertility intentions and long-acting reversible contraceptive use among HIV-negative single mothers in Zambia.

BACKGROUND: Integrating family planning interventions with HIV studies in developing countries has been shown to prevent mother-to-child HIV transmission and simultaneously reduce HIV and unintended pregnancy in high-risk populations. As part of a prospective cohort study on HIV incidence and risk factors in Zambian women having unprotected sex, we also offered family planning counseling and immediate access to long-acting reversible contraceptives. Although long-acting reversible contraceptives are the most effective form of contraception, many Zambian women are limited to oral or injectable methods because of a lack of knowledge or method availability. This project offers to single mothers who are enrolled in a cohort study information about and access to long-acting reversible contraceptives at enrollment and at each follow-up visit. OBJECTIVE: This study evaluates how fertility intentions affect long-acting reversible contraceptive use in HIV-negative single mothers in Zambia. Our primary outcome was long-acting reversible contraceptive use throughout the study participation. We also estimated rates of long-acting reversible contraceptive uptake and discontinuation. We specifically studied single mothers because they are at high risk for unintended pregnancy, which can have significant negative ramifications on their financial, social, and psychologic circumstances. STUDY DESIGN: From 2012-2017, Zambia Emory HIV Research Project recruited 521 HIV-negative single mothers ages 18-45 years from government clinics in Lusaka and Ndola, Zambia's 2 largest cities. Participants were followed every 3 months for up to 5 years. At each visit, we discussed fertility goals and contraceptive options and offered a long-acting reversible method to any woman who was not pregnant or who already was using a long-acting reversible or permanent contraceptive method. Data were collected on demographic factors, sexual behavior, and reproductive history. Multivariable logistic regression was used to model baseline fertility intentions with long-acting reversible contraceptive use. RESULTS: We enrolled 518 women; 57 women did not return for any follow-up visits. There was a significant increase in long-acting reversible contraceptive use during the study. At baseline, 93 of 518 women (18%) were using a long-acting reversible method, and 151 of 461 women (33%) used a long-acting reversible method at the end of follow-up period (P<.0001). Four women chose an intrauterine device, and 91 women chose an implant for their first uptake event. After we adjusted the data for other confounders, we found that women in Ndola who did not desire any more children were more likely to use a long-acting reversible contraceptive (adjusted prevalence ratio, 2.02; 95% confidence interval, 1.88-3.42). During follow up, 37 of 183 long-acting reversible contraceptive users (20%) discontinued their method; women who desired future children at baseline were more likely to discontinue earlier (P=.016). CONCLUSION: This study demonstrates that integrated family planning services can increase long-acting reversible contraceptive use successfully among Zambian single mothers, who are a vulnerable population that disproportionately is affected by unintended pregnancy. A steady increase in use over time confirms the importance of repeated messaging about these unfamiliar methods. Thus, it is imperative that family planning interventions target single mothers in developing countries to promote effective contraceptive use.

Uptake of long acting reversible contraception following integrated couples HIV and fertility goal-based family planning counselling in Catholic and non-Catholic, urban and rural government health centers in Kigali, Rwanda.

BACKGROUND: When integrated with couples' voluntary HIV counselling and testing (CVCT), family planning including long acting reversible contraceptives (LARC) addresses prongs one and two of prevention of mother-to-child transmission (PMTCT). METHODS: In this observational study, we enrolled equal numbers of HIV concordant and discordant couples in four rural and four urban clinics, with two Catholic and two non-Catholic clinics in each area. Eligible couples were fertile, not already using a LARC method, and wished to limit or delay fertility for at least 2 years. We provided CVCT and fertility goal-based family planning counselling with the offer of LARC and conducted multivariate analysis of clinic, couple, and individual predictors of LARC uptake. RESULTS: Of 1290 couples enrolled, 960 (74%) selected LARC: Jadelle 5-year implant (37%), Implanon 3-year implant (26%), or copper intrauterine device (IUD) (11%). Uptake was higher in non-Catholic clinics (85% vs. 63% in Catholic clinics, p < 0.0001), in urban clinics (82% vs. 67% in rural clinics, p < 0.0001), and in HIV concordant couples (79% vs. 70% of discordant couples, p = .0005). Religion of the couple was unrelated to clinic religious affiliation, and uptake was highest among Catholics (80%) and lowest among Protestants (70%) who were predominantly Pentecostal. In multivariable analysis, urban location and non-Catholic clinic affiliation, Catholic religion of woman or couple, younger age of men, lower educational level of both partners, non-use of condoms or injectable contraception at enrollment, prior discussion of LARC by the couple, and women not having concerns about negative side effects of implant were associated with LARC uptake. CONCLUSIONS: Fertility goal-based LARC recommendations combined with couples' HIV counselling and testing resulted in a high uptake of LARC methods, even among discordant couples using condoms for HIV prevention, in Catholic clinics, and in rural populations. This model successfully integrates prevention of HIV and unplanned pregnancy.

Loss to follow-up among female sex workers in Zambia: findings from a five-year HIV-incidence cohort.

HIV-incidence studies are used to identify at-risk populations for HIV-prevention trials and interventions, but loss to follow-up (LTFU) can bias results if participants who remain differ from those who drop out. We investigated the incidence of and factors associated with LTFU among Zambian female sex workers (FSWs) in an HIV-incidence cohort from 2012 to 2017. Enrolled participants returned at month one, month three and quarterly thereafter. FSWs were considered LTFU if they missed six consecutive months, or if their last visit was six months before the study end date. Of 420 FSWs, 139 (33%) were LTFU at a rate of 15.7 per 100 person years. In multivariable analysis, LTFU was greater for FSWs who never used alcohol, began sex work above the age of consent, and had a lower volume of new clients. Our study appeared to retain FSWs in most need of HIV-prevention services offered at follow-up.

Control of the HIV-1 Load Varies by Viral Subtype in a Large Cohort of African Adults With Incident HIV-1 Infection.

Few human immunodeficiency virus (HIV)-infected persons can maintain low viral levels without therapeutic intervention. We evaluate predictors of spontaneous control of the viral load (hereafter, "viral control") in a prospective cohort of African adults shortly after HIV infection. Viral control was defined as ≥2 consecutively measured viral loads (VLs) of ≤10 000 copies/mL after the estimated date of infection, followed by at least 4 subsequent measurements for which the VL in at least 75% was ≤10 000 copies/mL in the absence of ART. Multivariable logistic regression characterized predictors of viral control. Of 590 eligible volunteers, 107 (18.1%) experienced viral control, of whom 25 (4.2%) maintained a VL of 51-2000 copies/mL, and 5 (0.8%) sustained a VL of ≤50 copies/mL. The median ART-free follow-up time was 3.3 years (range, 0.3-9.7 years). Factors independently associated with control were HIV-1 subtype A (reference, subtype C; adjusted odds ratio [aOR], 2.1 [95% confidence interval {CI}, 1.3-3.5]), female sex (reference, male sex; aOR, 1.8 [95% CI, 1.1-2.8]), and having HLA class I variant allele B*57 (reference, not having this allele; aOR, 1.9 [95% CI, 1.0-3.6]) in a multivariable model that also controlled for age at the time of infection and baseline CD4+ T-cell count. We observed strong associations between infecting HIV-1 subtype, HLA type, and sex on viral control in this cohort. HIV-1 subtype is important to consider when testing and designing new therapeutic and prevention technologies, including vaccines.

Miscarriage among women in the United States Women's Interagency HIV Study, 1994-2017.

BACKGROUND: Relatively little is known about the frequency and factors associated with miscarriage among women living with HIV. OBJECTIVE: The objective of the study was to evaluate factors associated with miscarriage among women enrolled in the Women's Interagency HIV Study. STUDY DESIGN: We conducted an analysis of longitudinal data collected from Oct. 1, 1994, to Sept. 30, 2017. Women who attended at least 2 Women's Interagency HIV Study visits and reported pregnancy during follow-up were included. Miscarriage was defined as spontaneous loss of pregnancy before 20 weeks of gestation based on self-report assessed at biannual visits. We modeled the association between demographic, behavioral, and clinical covariates and miscarriage (vs live birth) for women overall and stratified by HIV status using mixed-model logistic regression. RESULTS: Similar proportions of women living with and without HIV experienced miscarriage (37% and 39%, respectively, P = .638). In adjusted analyses, smoking tobacco (adjusted odds ratio, 2.0), alcohol use (adjusted odds ratio, 4.0), and marijuana use (adjusted odds ratio, 2.0) were associated with miscarriage. Among women living with HIV, low HIV viral load (<4 log10 copies/mL) (adjusted odds ratio, 0.5) and protease inhibitor (adjusted odds ratio, 0.4) vs the nonuse of combination antiretroviral therapy use were protective against miscarriage. CONCLUSION: We did not find an increased odds of miscarriage among women living with HIV compared with uninfected women; however, poorly controlled HIV infection was associated with increased miscarriage risk. Higher miscarriage risk among women exposed to tobacco, alcohol, and marijuana highlight potentially modifiable behaviors. Given previous concern about antiretroviral therapy and adverse pregnancy outcomes, the novel protective association between protease inhibitors compared with non-combination antiretroviral therapy and miscarriage in this study is reassuring.