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.

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.

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.

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.

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.

Community health worker promotions increase uptake of long-acting reversible contraception in Rwanda.

BACKGROUND: We coordinated community health worker (CHW) promotions with training and support of government clinic nurses to increase uptake of long-acting reversible contraception (LARC), specifically the copper intrauterine device (IUD) and the hormonal implant, in Kigali, Rwanda. METHODS: From August 2015 to September 2016, CHW provided fertility goal-based family planning counseling focused on LARC methods, engaged couples in family planning counseling, and provided written referrals to clients expressing interest in LARC methods. Simultaneously, we provided didactic and practical training to clinic nurses on LARC insertion and removal. We evaluated: 1) aggregate pre- versus post-implementation LARC uptake as a function of CHW promotions, and 2) demographic factors associated with LARC uptake among women responding to CHW referrals. RESULTS: 7712 referrals were delivered by 184 CHW affiliated with eight government clinics resulting in 6072 family planning clinic visits (79% referral uptake). 95% of clinic visits resulted in LARC uptake (16% copper IUD, 79% hormonal implant). The monthly average for IUD insertions doubled from 29 prior to service implementation to 61 after (p < 0.0001), and the monthly average for implant insertions increased from 109 to 309 (p < 0.0001). In adjusted analyses, LARC uptake was associated (p < 0.05) with the CHW referral being issued to the couple (versus the woman alone, adjusted odds ratio, aOR = 2.6), having more children (aOR = 1.3), desiring more children (aOR = 0.8), and having a religious affiliation (aOR = 2.9 Protestant, aOR = 3.1 Catholic, aOR = 2.5 Muslim each versus none/other). Implant versus non-LARC uptake was associated with having little or no education; meanwhile, having higher education was associated with IUD versus implant uptake. CONCLUSIONS: Fertility goal-based and couple-focused family planning counseling delivered by CHW, coupled with LARC training and support of nursing staff, substantially increased uptake of LARC methods.

Erratum to: Risky Sex and HIV Acquisition Among HIV Serodiscordant Couples in Zambia, 2002-2012: What Does Alcohol Have To Do With It?

The article Risky Sex and HIV Acquisition Among HIV Serodiscordant Couples in Zambia, 2002-2012: What Does Alcohol Have To Do With It?, written by Dvora Joseph Davey, William Kilembe, Kristin M. Wall, Naw Htee Khu, Ilene Brill, Bellington Vwalika, Elwyn Chomba, Joseph Mulenga, Amanda Tichacek, Marjan Javanbakht, W. Scott Comulada, Susan Allen, Pamina M. Gorbach, was originally published Online First without open access. After publication in volume 21, issue 7, pages 1892-1903, the author decided to opt for Open Choice and to make the article an open access publication. Therefore, the copyright of the article has been changed to

Couples' voluntary HIV counseling and testing provider training evaluation, Zambia.

With the expansion of couples' voluntary HIV counseling and testing (CVCT) in urban Zambia, there is a growing need to evaluate CVCT provider trainings to ensure that couples are receiving quality counseling and care. We evaluated provider knowledge scores, pre- and post-training and predictors of pre- and post-training test scores. Providers operating in 67 government clinics in four Copperbelt Province cities were trained from 2008 to 2013 in three domains: counseling, rapid HIV laboratory testing and data management. Trainees received pre- and post-training tests on domain-specific topics. Pre- and post-training test scores were tabulated by provider demographics and training type, and paired t-tests evaluated differences in pre- and post-training test scores. Multivariable ANCOVA determined predictors of pre- and post-training test scores. We trained 1226 providers, and average test scores increased from 68.8% pre-training to 83.8% post-training (p < 0.001). Test scores increased significantly for every demographic group and training type (p < 0.001) with one exception-test scores did not significantly increase for those receiving counseling or data management training who had less than a high school education. In multivariable analysis, higher educational level and having a medical background were predictive of a higher pre-test score; higher pre-test scores and having a medical background were predictive of higher post-test scores. Pre- and post-test assessments are critical to ensure quality services, particularly as task-shifting from medical to lay staff becomes more common. Assessments showed that our CVCT trainings are successful at increasing knowledge, and that those with lower education may benefit from repeat trainings.

Rwandan stakeholder perspectives of integrated family planning and HIV services.

The purpose of this qualitative study was to understand the knowledge, attitudes, and practices among key Rwandan policymakers and stakeholders related to family planning (FP) and integrated HIV/FP services. Motivational in-depth interview format and content was developed after an extensive policy review. A convenience sample of 10 high-level HIV and FP Rwandan policymakers and stakeholders completed the interview. Stakeholders demonstrated strong foundational knowledge of HIV and FP. Given the choice, stakeholders would allocate more monies to FP and less to HIV than currently distributed. Respondents felt that improved FP method knowledge, especially long-acting reversible contraception, among clients/couples and providers, was needed to address myths, misconceptions, and biases. The most often cited way to integrate HIV/FP services was development of integrated tools (eg, training materials, data collection tools, and advocacy and policy guidance). We recommend strategies for policy advancement supportive of HIV/FP service integration inclusive of couples and long-acting reversible contraception methods.

Sustained effect of couples' HIV counselling and testing on risk reduction among Zambian HIV serodiscordant couples.

BACKGROUND: We present temporal trends in self-reported and biological markers of unprotected sex and sex with concurrent partners in discordant couples receiving couples' voluntary HIV counselling and testing (CVCT). METHODS: Heterosexual Zambian HIV-serodiscordant couples were enrolled into longitudinal follow-up in an open cohort (1994-2012). Multivariable Anderson-Gill models explored predictors of self-report and biological indicators of unprotected sex within (including sperm on a vaginal swab, incident pregnancy or incident linked HIV infection) and outside (including self-report, STI and unlinked HIV infection) the union. Measures of secular trends in baseline measures were also examined. RESULTS: At enrolment of 3049 couples, men were 35 years old on average, women were 29 years, and couples had been together for an average of 7 years. M+F- couples reported an average of 16.6 unprotected sex acts in the 3 months prior to enrolment (pre-CVCT), dropping to 5.3 in the >0-3 month interval, and 2.0 in >6 month intervals (p-trend <0.001). Corresponding values for M-F+ couples were 22.4 unprotected sex acts in the 3 months prior enrolment, dropping to 5.2 in the >0-3 month interval, and 3.1 in >6 month intervals (p-trend <0.001). Significant reductions in self-report and biological markers of outside partners were also noted. Predictors of unprotected sex between study partners after CVCT included prevalent pregnancy (adjusted HR, aHR=1.6-1.9); HIV+ men being circumcised (aHR=1.2); and HIV- women reporting sex with outside partners (aHR=1.3), alcohol (aHR=1.2), injectable (aHR=1.4) or oral (aHR=1.4) contraception use. Fertility intentions were also predictive of unprotected sex (aHR=1.2-1.4). Secular trends indicated steady declines in reported outside partners and STIs. CONCLUSION: Reductions in self-reported unprotected sex after CVCT were substantial and sustained. Reinforced risk-reduction counselling in pregnant couples, couples desiring children and couples with HIV- women having outside partners or using alcohol or injectable or oral contraception are indicated.

Risky Sex and HIV Acquisition Among HIV Serodiscordant Couples in Zambia, 2002-2012: What Does Alcohol Have To Do With It?

In this paper we evaluate the effects of heavy alcohol consumption on sexual behavior, HIV acquisition, and antiretroviral treatment (ART) initiation in a longitudinal open cohort of 1929 serodiscordant couples in Lusaka, Zambia from 2002 to 2012. We evaluated factors associated with baseline heavy alcohol consumption and its association with condomless sex with the study partner, sex outside of the partnership, and ART initiation using multivariable logistic regression. We estimated the effect of alcohol consumption on HIV acquisition using multivariable Cox models. Baseline factors significantly associated with women's heavy drinking (drunk weekly or more in 12-months before enrollment) included woman's older age (adjusted prevalence odds ratio [aPOR] = 1.04), partner heavy drinking (aPOR = 3.93), and being HIV-infected (aPOR = 2.03). Heavy drinking among men was associated with less age disparity with partner (aPOR per year disparity = 0.97) and partner heavy drinking (aPOR = 1.63). Men's being drunk daily (aOR = 1.18), women's being drunk less than monthly (aOR = 1.39) vs. never drunk and being in a male HIV-negative and female HIV-positive union (aOR = 1.45) were associated with condomless sex. Heavy alcohol use was associated with having 1 or more outside sex partners among men (aOR drunk daily = 1.91, drunk weekly = 1.32, drunk monthly = 2.03 vs. never), and women (aOR drunk monthly = 2.75 vs. never). Being drunk weekly or more increased men's risk of HIV acquisition (adjusted hazard ratio [aHR] = 1.72). Men and women being drunk weekly or more was associated (p < 0.1) with women's seroconversion (aHR = 1.42 and aHR = 3.71 respectively). HIV-positive women who were drunk monthly or more had lower odds of initiating ART (aOR = 0.83; 95% CI = 0.70-0.99) adjusting for age, months since baseline and previous pregnancies. Individuals in HIV-serodiscordant couples who reported heavy drinking had more outside sex partnerships and condomless sex with their study partner and were more likely to acquire HIV. HIV-positive women had lower odds of initiating ART if they were heavy drinkers.

Hormonal Contraceptive Use Among HIV-Positive Women and HIV Transmission Risk to Male Partners, Zambia, 1994-2012.

BACKGROUND: Evidence on the association between female-to-male human immunodeficiency virus (HIV) transmission risk and hormonal contraception is sparse and conflicting. METHODS: Heterosexual HIV-discordant couples from Lusaka, Zambia, were followed longitudinally at 3 month-intervals from 1994 to 2012. The impact of hormonal contraception on time to HIV transmission from HIV-positive women to their HIV-negative male partners (M-F+) was evaluated. RESULTS: Among 1601 M-F+ couples, 171 genetically linked HIV transmissions occurred in men over 3216 couple-years (5.3 transmissions/100 couple-years; 95% confidence interval [CI], 4.5-6.2). In multivariable Cox models, neither injectable (adjusted hazard ratio [aHR], 0.6; 95% CI, .4-1.2), oral contraceptive pill (aHR, 0.8; 95% CI, .3-2.1), nor implant (aHR, 0.8; 95% CI, .5-1.4) use was associated with HIV transmission, relative to nonhormonal methods, after controlling for the man's age at baseline and time-varying measures of pregnancy, self-reported unprotected sex with the study partner, sperm present on a vaginal swab wet mount, genital inflammation of either partner, genital ulceration of the man, and first follow-up interval. Sensitivity analyses, including marginal structural modeling and controlling for viral load and fertility intentions available in a subset of couples, led to similar conclusions. CONCLUSIONS: Our findings suggest null associations between hormonal contraception and risk of female-to-male HIV transmission. We support efforts to increase the contraceptive method mix for all women, regardless of HIV serostatus, along with reinforced condom counseling for HIV-serodiscordant couples.