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: 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., INTRODUCTION Incident HIV infections in sub‐Saharan Africa have fallen 13% over recent years due to global prevention efforts [1]. However, this decline in new infections is slowing, gaps in the [...]

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 tie‐breaker 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., Background Sub‐Saharan Africa remains the focal point of the HIV pandemic, with the largest percentage of HIV‐positive individuals and the greatest number of new infections per year [1]. Most new [...]

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. [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]

Sexually transmitted infections (STIs) in women caused by Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) are epidemiologically distinct. In this study, associations with sociodemographic and clinical risk factors are explored separately for CT and NG. Multivariate logistic regression (MLR) models quantify associations between potential CT and/or NG risk factors within a cross-sectional study of high-risk women in two Zambian cities, Lusaka and Ndola. CT was associated with living in Lusaka, younger age, and literacy. Long-acting reversible contraception (LARC) was predictive of CT in Ndola, but protective in Lusaka. In Lusaka only, CT was associated with lower education and reported unprotected sex. NG was associated with younger age, lower education, concurrent Trichomonas vaginalis, bacterial vaginosis, and incident syphilis infection. Signs and symptoms were rare and not associated with either infection. CT was more prevalent, nearly 11%, compared to NG, 6.8%. The higher prevalence of CT could explain the lack of association with other STIs. The associations observed with NG could be the result of high-risk sexual networks or lack of protective immunity. Risk factors for CT and NG are distinct and may differ geographically, which should be considered when developing diagnostic tools or guiding presumptive treatment in specific populations. [ABSTRACT FROM AUTHOR]

Female sex workers (FSWs) are at high risk of HIV infection. Alcohol use prior to sex can compound this risk. We investigated the factors associated with having sex under the influence of alcohol among Zambian FSWs. Community health workers and peer FSWs recruited 331 HIV-negative FSWs in Lusaka and Ndola. In a cross-sectional survey, we asked FSWs how often they had sex under the influence of alcohol in the previous month and categorised responses as 'always' and 'not always'. The adjusted odds ratios (AORs) of always having sex under the influence of alcohol were higher among FSWs who charged clients medium (AOR: 2.20, 95% confidence interval [CI]: 1.04–4.68) and low fees (AOR: 2.65, 95% CI: 1.26–5.60) for sex versus high fees; received 9–19 (AOR: 2.37, 95% CI: 1.15–4.91) and 20 or more clients per month (AOR: 3.06, 95% CI: 1.47–6.37) versus up to 8 clients per month; and never used condoms versus always used condoms with clients (AOR: 4.21, 95% CI: 1.53–11.55). FSWs who always used alcohol before sex appeared more likely to engage in riskier sex and charge clients lower fees. Interventions for financial empowerment and alcohol risk reduction should complement existing HIV prevention interventions for FSWs. [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: 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. [ABSTRACT FROM AUTHOR]

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. [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]

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., (Copyright © 2020 American Society for Microbiology.)