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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. [ABSTRACT FROM AUTHOR]

Objective: To examine the relationship between hormonal contraception and vaginal infections with bacterial vaginosis, vaginal candidiasis, or trichomoniasis.Methods: Couples who were human immunodeficiency virus (HIV) serodiscordant in Zambia were enrolled in a longitudinal cohort study. From 1994 to 2002, both partners were seen quarterly and received physical exams including genital examinations. Separate rates for three outcome infections of interest (bacterial vaginosis, vaginal candidiasis, and trichomoniasis) were calculated. Bivariate associations between baseline and time-varying covariates and outcome infections of interest were evaluated using unadjusted Anderson-Gill survival models. Adjusted hazard ratios (aHRs) were generated using multivariable Anderson-Gill survival models that included demographic and clinical factors associated with both hormonal contraceptive use and each infection of interest.Results: There were 1,558 cases of bacterial vaginosis, 1,529 cases of vaginal candidiasis, and 574 cases of trichomoniasis over 2,143 person-years of observation. Depot medroxyprogesterone acetate (DMPA) users had significantly lower rates of trichomoniasis and bacterial vaginosis. In adjusted models, DMPA was protective for bacterial vaginosis (aHR=0.72; 95% CI 0.54-0.95), candidiasis (aHR 0.75, 95% CI 0.57-1.00) and trichomoniasis (aHR=0.43, 95% CI 0.25-0.74). Oral contraceptive pills were protective for candidiasis (aHR=0.79, 95% CI 0.65-0.97).Conclusion: We confirm that DMPA use was associated with reduced rates of the three most common causes of vaginitis, and oral contraceptive pill use was associated with reduced rates of candidiasis among women in couples who were HIV discordant. [ABSTRACT FROM AUTHOR]

Background: Risks to mother and fetus following Ebola virus infection are very high. Evaluation of safety and immunogenicity of non-replicating Ebola vaccine candidates is a priority for use in pregnant women. This is the protocol for a randomized, open-label, single-center phase 3 clinical trial of the safety, reactogenicity, and immunogenicity of the 2-dose Ebola vaccine regimen in healthy adult pregnant women. This 2-dose regimen has been shown to be safe, judged effective, and approved in non-pregnant populations.Methods: A total of 2000 adult (≥ 18 years of age) pregnant women will be enrolled from antenatal care facilities in Western Rwanda and randomized (1:1) to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo (group A)) or control (unvaccinated pregnant women (group B)). The primary objectives are to (1) assess adverse maternal/fetal outcomes in randomized pregnant women up to 1.5 months after delivery and (2) assess adverse neonatal/infant outcomes in neonates/infants born to randomized women up to 3.5 months after birth. The frequency and relatedness of all serious adverse events in women and newborns from randomization or birth, respectively, until study end will be reported. The reactogenicity and unsolicited adverse events of the 2-dose Ebola vaccine regimen in all vaccinated pregnant women (group A) will be reported. We will also assess the immunogenicity of the 2-dose Ebola vaccine regimen in 150 pregnant women who are anticipated to receive both vaccine doses within the course of their pregnancy (a subset of the 1000 pregnant vaccinated women from group A) compared to 150 non-pregnant women vaccinated after delivery (a subset of group B). The persistence of maternal antibodies in 75 infants born to women from the group A subset will be assessed. Exploratory analyses include assessment of acceptability of the 2-dose Ebola vaccine regimen among group A and assessment of maternal antibodies in breast milk in 50 women from group A and 10 controls (women from group B prior to vaccination).Discussion: This study is intended to support a label variation to relax restrictions on use in pregnant women, a vulnerable population with high medical need.Trial Registration: Clinicaltrials.gov NCT04556526 . September 21, 2020. [ABSTRACT FROM AUTHOR]

Violence against women is a known risk factor for HIV and affects female sex workers (FSW) in sub-Saharan Africa. Little is known about the magnitude and determinants of violence against FSW in Zambia, where HIV and gender-based violence prevalence are high. We conducted a cross-sectional study, using multivariable logistic regression, to determine the prevalence and correlates of client-initiated physical violence among 419 FSW in Lusaka and Ndola. The prevalence of client-initiated physical violence was 39%. The odds of violence were higher for FSW who: lived in Lusaka, recruited clients from the street, serviced clients in the clients' homes, had a physically forced sexual debut, and had a higher client volume. Our results call for safer working spaces for FSW and violence prevention interventions for their male clients. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: Couples' voluntary HIV counselling and testing (CVCT) is a high‐impact HIV prevention intervention in Rwanda and Zambia. Our objective was to model the cost‐per‐HIV infection averted by CVCT in six African countries guided by an HIV prevention cascade framework. The HIV prevention cascade as yet to be applied to evaluating CVCT effectiveness or cost‐effectiveness. Methods: We defined a priority population for CVCT in Africa as heterosexual adults in stable couples. Based on our previous experience nationalizing CVCT in Rwanda and scaling‐up CVCT in 73 clinics in Zambia, we estimated HIV prevention cascade domains of motivation for use, access and effectiveness of CVCT as model parameters. Costs‐per‐couple tested were also estimated based on our previous studies. We used these parameters as well as country‐specific inputs to model the impact of CVCT over a five‐year time horizon in a previously developed and tested deterministic compartmental model. We consider six countries across Africa with varied HIV epidemics (South Africa, Zimbabwe, Kenya, Tanzania, Ivory Coast and Sierra Leone). Outcomes of interest were the proportion of HIV infections averted by CVCT, nationwide CVCT implementation costs and costs‐per‐HIV infection averted by CVCT. We applied 3%/year discounting to costs and outcomes. Univariate and Monte Carlo multivariate sensitivity analyses were conducted. Results: We estimated that CVCT could avert between 54% (Sierra Leone) and 62% (South Africa) of adult HIV infections. Average costs‐per‐HIV infection averted were lowest in Zimbabwe ($550) and highest in South Africa ($1272). Nationwide implementations would cost between 7% (Kenya) and 21% (Ivory Coast) of a country's President's Emergency Plan for AIDS Relief (PEPFAR) budget over five years. In sensitivity analyses, model outputs were most sensitive to estimates of cost‐per‐couple tested; the proportion of adults in heterosexual couples and HIV prevention cascade domains of CVCT motivation and access. Conclusions: Our model indicates that nationalized CVCT could prevent over half of adult HIV infections for 7% to 21% of the modelled countries' five‐year PEPFAR budgets. While other studies have indicated that CVCT motivation is high given locally relevant promotional and educational efforts, without required indicators, targets and dedicated budgets, access remains low. [ABSTRACT FROM AUTHOR]

Background: The impact and cost-effectiveness of couples' voluntary HIV counselling and testing (CVCT) has not been quantified in real-world settings. We quantify cost-per-HIV-infection averted by CVCT in Zambia from the donor's perspective.Methods: From 2010 to 2016, CVCT was established in 73 Zambian government clinics. The cost-per-HIV-infection averted (CHIA) of CVCT was calculated using observed expenditures and effectiveness over longitudinal follow-up. These observed measures parameterized hypothetical 5-year nationwide implementations of: 'CVCT'; 'treatment-as-prevention (TasP) for discordant couples' identified by CVCT; and 'population TasP' for all HIV+ cohabiting persons identified by individual testing.Results: In all, 207 428 couples were tested (US $52/couple). Among discordant couples in which HIV+ partners self-reported antiretroviral therapy (ART), HIV incidence was 8.5/100 person-years before and 1.8/100 person-years after CVCT (79% reduction). Corresponding reductions for non-ART-using discordant and concordant negative couples were 63% and 47%, respectively. CVCT averted an estimated 58% of new infections at US $659 CHIA. In nationwide implementation models, CVCT would prevent 17 times the number of infections vs 'TasP for discordant couples' at 86% of the cost, and nine times the infections vs 'population TasP' at 28% of the cost.Conclusions: CVCT is a cost-effective, feasible prevention strategy in Zambia. We demonstrate the novel, added effectiveness of providing CVCT to ART users, for whom ART use alone only partially mitigated transmission risk. Our results indicate a major policy shift (supporting development of CVCT indicators, budgets and targets) and have clinical implications (suggesting promotion of CVCT in ART clinics as a high-impact prevention strategy). [ABSTRACT FROM AUTHOR]

Background: We examined relationships between schistosome infection, HIV transmission or acquisition, and all-cause death. Methods: We retrospectively tested baseline sera from a heterosexual HIV-discordant couple cohort in Lusaka, Zambia with follow-up from 1994–2012 in a nested case-control design. Schistosome-specific antibody levels were measured by ELISA. Associations between baseline antibody response to schistosome antigens and incident HIV transmission, acquisition, and all-cause death stratified by gender and HIV status were assessed. In a subset of HIV- women and HIV+ men, we performed immunoblots to evaluate associations between Schistosoma haematobium or Schistosoma mansoni infection history and HIV incidence. Results: Of 2,145 individuals, 59% had positive baseline schistosome-specific antibody responses. In HIV+ women and men, baseline schistosome-specific antibodies were associated with HIV transmission to partners (adjusted hazard ratio [aHR] = 1.8, p<0.005 and aHR = 1.4, p<0.05, respectively) and death in HIV+ women (aHR = 2.2, p<0.001). In 250 HIV- women, presence of S. haematobium-specific antibodies was associated with increased risk of HIV acquisition (aHR = 1.4, p<0.05). Conclusion: Schistosome infections were associated with increased transmission of HIV from both sexes, acquisition of HIV in women, and increased progression to death in HIV+ women. Establishing effective prevention and treatment strategies for schistosomiasis, including in urban adults, may reduce HIV incidence and death in HIV+ persons living in endemic areas. [ABSTRACT FROM AUTHOR]

Background: Patient identification within and between health services is an operational challenge in many resource-limited settings. When following HIV risk groups for service provision and in the context of vaccine trials, patient misidentification can harm patient care and bias trial outcomes. Electronic fingerprinting has been proposed to identify patients over time and link patient data between health services. The objective of this study was to determine 1) the feasibility of implementing an electronic-fingerprint linked data capture system in Zambia and 2) the acceptability of this system among a key HIV risk group: female sex workers (FSWs). Methods: Working with Biometrac, a US-based company providing biometric-linked healthcare platforms, an electronic fingerprint-linked data capture system was developed for use by field recruiters among Zambian FSWs. We evaluated the technical feasibility of the system for use in the field in Zambia and conducted a pilot study to determine the acceptability of the system, as well as barriers to uptake, among FSWs. Results: We found that implementation of an electronic fingerprint-linked patient tracking and data collection system was feasible in this relatively resource-limited setting (false fingerprint matching rate of 1/1000 and false rejection rate of <1/10,000) and was acceptable among FSWs in a clinic setting (2 % refusals). However, our data indicate that less than half of FSWs are comfortable providing an electronic fingerprint when recruited while they are working. The most common reasons cited for not providing a fingerprint (lack of privacy/confidentiality issues while at work, typically at bars or lodges) could be addressed by recruiting women during less busy hours, in their own homes, in the presence of "Queen Mothers" (FSW organizers), or in the presence of a FSW that has already been fingerprinted. Conclusions: Our findings have major implications for key population research and improved health services provision. However, more work needs to be done to increase the acceptability of the electronic fingerprint-linked data capture system during field recruitment. This study indicated several potential avenues that will be explored to increase acceptability. [ABSTRACT FROM AUTHOR]

Background: Many HIV voluntary testing and counselling centres in Africa use rapid antibody tests, in parallel or in sequence, to establish same-day HIV status. The interpretation of indeterminate or discrepant results between different rapid tests on one sample poses a challenge. We investigated the use of an algorithm using three serial rapid HIV tests in cohabiting couples to resolve unclear serostatuses. Methods: Heterosexual couples visited the Rwanda Zambia HIV Research Group testing centres in Kigali, Rwanda, and Lusaka, Zambia, to assess HIV infection status. Individuals with unclear HIV rapid antibody test results (indeterminate) or discrepant results were asked to return for repeat testing to resolve HIV status. If either partner of a couple tested positive or indeterminate with the screening test, both partners were tested with a confirmatory test. Individuals with indeterminate or discrepant results were further tested with a tiebreaker and monthly retesting. HIV-RNA viral load was determined when HIV status was not resolved by follow-up rapid testing. Individuals were classified based on two of three initial tests as "Positive", "Negative" or "Other". Follow-up testing and/or HIV-RNA viral load testing determined them as "Infected", "Uninfected" or "Unresolved". Results: Of 45,820 individuals tested as couples, 2.3% (4.1% of couples) had at least one discrepant or indeterminate rapid result. A total of 65% of those individuals had follow-up testing and of those individuals initially classified as "Negative" by three initial rapid tests, less than 1% were resolved as "Infected". In contrast, of those individuals with at least one discrepant or indeterminate result who were initially classified as "Positive", only 46% were resolved as "Infected", while the remainder was resolved as "Uninfected" (46%) or "Unresolved" (8%). A positive HIV serostatus of one of the partners was a strong predictor of infection in the other partner as 48% of individuals who resolved as "Infected" had an HIV-infected spouse. Conclusions: In more than 45,000 individuals counselled and tested as couples, only 5% of individuals with indeterminate or discrepant rapid HIV test results were HIV infected. This represented only 0.1% of all individuals tested. Thus, algorithms using screening, confirmatory and tie-breaker rapid tests are reliable with two of three tests negative, but not when two of three tests are positive. False positive antibody tests may persist. HIV-positive partner serostatus should prompt repeat testing. [ABSTRACT FROM AUTHOR]

Background Risk of heterosexual HIV-1 transmission is elevated in the presence of sexually transmitted infections (STIs) such as chlamydia (CT) and gonorrhea (NG). Syndromic management is a common, low-resource, approach to detecting STIs. However, CT and/or NG infections in women are often asymptomatic and therefore missed by syndromic management. Molecular testing for STIs is highly sensitive, but time and cost restraints preclude implementation of these technologies in resource-limited settings. Pooling samples for testing together in GeneXpert cartridges is one strategy for reducing the cost per individual tested. Methods This project describes the development of a pooling strategy based on social and demographic factors associated with CT/NG prevalence rates in a cohort of high-risk women in Zambia. Logistic regression modeling was used to predict the probability of a positive CT/NG test result in the presence of various factors. Data from a 2016 cross-sectional sub-study on intra-vaginal practices in 509 women was examined and an easy-to-use diagnostic screening checklist was created to categorize women by probability of testing positive on the GeneXpert. An algorithm considering cost of each test and prevalence of disease in each group determined the optimal pool size for each risk category. Results Logistic regression identified CT/NG to be associated with: city, age, education, long-acting reversible contraception usage, and laboratory results for bacterial vaginosis, Trichomonas vaginalis , and incident syphilis on the day of CT/NG testing. Signs and symptoms were not found to be associated. The overall prevalence of either CT and/or NG infection in this population was 17%. Low, middle, and high-risk groups could be separated based on checklist score with 7.52%, 18.30%, and 46.51% CT/NG prevalence, respectively. Conclusion Pooling women with similar CT/NG predictive factors together, or testing those at highest risk individually, reduces the cost per test. Further implementation of this tool to guide presumptive treatment, in lieu of molecular testing, increases the cost-saving potential. The strategies described in this study are applicable to other low-resource clinical settings seeking to provide the accuracy of molecular testing with a reduced financial burden. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Background: Patient identification within and between health services is an operational challenge in many resource-limited settings. When following HIV risk groups for service provision and in the context of vaccine trials, patient misidentification can harm patient care and bias trial outcomes. Electronic fingerprinting has been proposed to identify patients over time and link patient data between health services. The objective of this study was to determine 1) the feasibility of implementing an electronic-fingerprint linked data capture system in Zambia and 2) the acceptability of this system among a key HIV risk group: female sex workers (FSWs).Methods: Working with Biometrac, a US-based company providing biometric-linked healthcare platforms, an electronic fingerprint-linked data capture system was developed for use by field recruiters among Zambian FSWs. We evaluated the technical feasibility of the system for use in the field in Zambia and conducted a pilot study to determine the acceptability of the system, as well as barriers to uptake, among FSWs.Results: We found that implementation of an electronic fingerprint-linked patient tracking and data collection system was feasible in this relatively resource-limited setting (false fingerprint matching rate of 1/1000 and false rejection rate of <1/10,000) and was acceptable among FSWs in a clinic setting (2% refusals). However, our data indicate that less than half of FSWs are comfortable providing an electronic fingerprint when recruited while they are working. The most common reasons cited for not providing a fingerprint (lack of privacy/confidentiality issues while at work, typically at bars or lodges) could be addressed by recruiting women during less busy hours, in their own homes, in the presence of "Queen Mothers" (FSW organizers), or in the presence of a FSW that has already been fingerprinted.Conclusions: Our findings have major implications for key population research and improved health services provision. However, more work needs to be done to increase the acceptability of the electronic fingerprint-linked data capture system during field recruitment. This study indicated several potential avenues that will be explored to increase acceptability. [ABSTRACT FROM AUTHOR]