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AbstractIntroductionFemale sex workers (FSWs) experience overlapping burdens of HIV, sexually transmitted infections and unintended pregnancy. Pre‐exposure prophylaxis (PrEP) is highly efficacious for HIV prevention. It represents a promising strategy to reduce HIV acquisition risks among FSWs specifically given complex social and structural factors that challenge consistent condom use. However, the potential impact on unintended pregnancy has garnered little attention. We discuss the potential concerns and opportunities for PrEP to positively or negatively impact the sexual and reproductive health and rights (SRHR) of FSWs.DiscussionFSWs have high unmet need for effective contraception and unintended pregnancy is common in low‐ and middle‐income countries. Unintended pregnancy can have enduring health and social effects for FSWs, including consequences of unsafe abortion and financial impacts affecting subsequent risk‐taking. It is possible that PrEP could negatively impact condom and other contraceptive use among FSWs due to condom substitution, normalization, external pressures or PrEP provision by single‐focus services. There are limited empirical data available to assess the impact of PrEP on pregnancy rates in real‐life settings. However, pregnancy rates are relatively high in PrEP trials and modelling suggests a potential two‐fold increase in condomless sex among FSWs on PrEP, which, given low use of non‐barrier contraceptive methods, would increase rates of unintended pregnancy. Opportunities for integrating family planning with PrEP and HIV services may circumvent these concerns and support improved SRHR. Synergies between PrEP and family planning could promote uptake and maintenance for both interventions. Integrating family planning into FSW‐focused community‐based HIV services is likely to be the most effective model for improving access to non‐barrier contraception among FSWs. However, barriers to integration, such as provider skills and training and funding mechanisms, need to be addressed.ConclusionsAs PrEP is scaled up among FSWs, there is growing impetus to consider integrating family planning services with PrEP delivery in order to better meet the diverse SRHR needs of FSWs and to prevent unintended consequences. Programme monitoring combined with research can close data gaps and mobilize adequate resources to deliver comprehensive SRHR services respectful of all women's rights.

BACKGROUND: Key populations who bear a disproportionate burden of HIV, including female sex workers, men who have sex with men, people who use drugs, transgender people, and incarcerated populations, have been understudied, especially in the context of broadly generalized HIV epidemics. Program and investment planning documents often do not take into account the data that do exist. Prior systematic reviews have been comprehensive, but lack sustainability and relevance over time. This review aims to synthesize all available data for key populations and present the data through an accessible, updatable user-friendly graphic interface. The outputs of this systematic review will serve as a resource for decision-makers, providing government stakeholders and donors with the tools to make evidence-based decisions for national planning. METHODS: We will conduct a systematic review of data published or made available between January 1, 2006, and January 1, 2019, that captures the burden of HIV, both prevalence and incidence estimates, HIV prevention and treatment cascades, key population size estimates, experienced violence, consistent condom use, and engagement with healthcare systems for female sex workers, men who have sex with men, people who use drugs, transgender people, and incarcerated populations. A team of reviewers will use Covidence to conduct two independent reviews of both title/abstract and full text for each article. REDCap will be used for data abstraction and storage. DISCUSSION: Findings from this systematic review and the development of the enhanced graphical interface to display data, along with ongoing efforts to build capacity among key stakeholders to better use and interpret available data, will help ensure that available epidemiologic data related to key populations can be appropriately used to guide large-scale HIV funding and programmatic responses. SYSTEMATIC REVIEW REGISTRATION: PROPSERO CRD42016047259 .

AbstractIntroduction: Implementation of safer conception services for HIV‐affected couples within primary healthcare clinics in resource‐limited settings remains limited. We review service utilization and safer conception strategy uptake during the first three years of Sakh'umndeni, which is a safer conception clinic in South Africa.Methods: Sakh'umndeni is located at Witkoppen Health and Welfare Centre, a high‐volume primary healthcare clinic in northern Johannesburg. Men and women desiring to conceive in less than or equal to six months and in relationships in which one or both partners are living with HIV are eligible for safer conception services. Clients receive a baseline health assessment and counselling around periconception HIV risk reduction strategies and choose which strategies they plan to use. Clients are followed‐up monthly. We describe client service utilization and uptake and continuation of safer conception methods. Factors associated with male partner attendance are assessed using robust Poisson regression.Results: Overall 440 individuals utilized the service including 157 couples in which both partners attended (55%) and 126 unaccompanied female partners. Over half of the couples (55%) represented were in serodiscordant/unknown status relationships. Higher economic status and HIV‐negative status of the women increased male partner involvement, while HIV‐negative status of the men decreased male involvement. Regarding safer conception strategies, uptake of antiretroviral therapy initiation (90%), vaginal self‐insemination among partnerships with HIV‐negative men (75%) and timed condomless intercourse strategies (48%) were variable, but generally high. Overall uptake of pre‐exposure prophylaxis (PrEP) was 23% and was lower among HIV‐negative men than women (7% vs. 44%, p < 0.001). Male medical circumcision (MMC) was used by 28% of HIV‐negative men. Over 80% of clients took up at least one recommended safer conception strategy. Continuation of selected strategies over attempted conception attempts was >60%.Conclusions: Safer conception strategies are generally used by clients per recommendations. High uptake of strategies suggests that the proposed combination prevention methods are acceptable to clients and appropriate for scale‐up; however, low uptake of PrEP and MMC among HIV‐negative men needs improvement. Targeted community‐based efforts to reach men unlinked to safer conception services are needed, alongside streamlined approaches for service scale‐up within existing HIV and non‐HIV service delivery platforms.

AbstractIntroductionHIV epidemic appraisals are used to characterize heterogeneity and inequities in the context of the HIV pandemic and the response. However, classic measures used in appraisals have been shown to underestimate disproportionate risks of onward transmission, particularly among key populations. In response, a growing number of modelling studies have quantified the consequences of unmet prevention and treatment needs (prevention gaps) among key populations as a transmission population attributable fraction over time (tPAFt). To aid its interpretation and use by programme implementers and policy makers, we outline and discuss a conceptual framework for understanding and estimating the tPAFt via transmission modelling as a measure of onward transmission risk from HIV prevention gaps; and discuss properties of the tPAFt.DiscussionThe distribution of onward transmission risks may be defined by who is at disproportionate risk of onward transmission, and under which conditions. The latter reflects prevention gaps, including secondary prevention via treatment: the epidemic consequences of which may be quantified by the tPAFt. Steps to estimating the tPAFt include parameterizing the acquisition and onward transmission risks experienced by the subgroup of interest, defining the most relevant counterfactual scenario, and articulating the time‐horizon of analyses and population among whom to estimate the relative difference in cumulative transmissions; such steps could reflect programme‐relevant questions about onward transmission risks. Key properties of the tPAFt include larger onward transmission risks over longer time‐horizons; seemingly mutually exclusive tPAFt measures summing to greater than 100%; an opportunity to quantify the magnitude of disproportionate onward transmission risks with a per‐capita tPAFt; and that estimates are conditional on what has been achieved so far in reducing prevention gaps and maintaining those conditions moving forward as the status quo.ConclusionsThe next generation of HIV epidemic appraisals has the potential to support a more specific HIV response by characterizing heterogeneity in disproportionate risks of onward transmission which are defined and conditioned on the past, current and future prevention gaps across subsets of the population.

AbstractIntroductionAdolescent girls and young women (AGYW) in sub‐Saharan Africa have emerged as a priority population in need of HIV prevention interventions. Secondary distribution of home‐based HIV self‐test kits by AGYW to male partners (MP) is a novel prevention strategy that complements pre‐exposure prophylaxis (PrEP), a female‐controlled prevention intervention. The objective of this analysis was to qualitatively operationalize two HIV prevention cascades through the lens of relationship dynamics for secondary distribution of HIV self‐tests to MP and PrEP for AGYW.MethodsFrom April 2018 to December 2018, 2200 HIV‐negative AGYW aged 16‐24 years were enrolled into an HIV prevention intervention which involved secondary distribution of self‐tests to MP and PrEP for AGYW; of these women, 91 participants or MP were sampled for in‐depth interviews based on their degree of completion of the two HIV prevention cascades. A grounded theory approach was used to characterize participants' relationship profiles, which were mapped to participants' engagement with the interventions.ResultsIn cases where AGYW had a MP with multiple partners, AGYW perceived both interventions as inviting distrust into the relationship and insinuating non‐monogamy. Many chose not to accept either intervention, while others accepted and attempted to deliver the self‐test kit but received a negative reaction from their MP. In the few cases where AGYW held multiple partnerships, both interventions were viewed as mechanisms for protecting one's health, and these AGYW exhibited confidence in accepting and delivering the self‐test kits and initiating PrEP. Women who indicated intimate partner violence experiences chose not to accept either intervention because they feared it would elicit a violent reaction from their MP. For AGYW in relationships described as committed and emotionally open, self‐test kit delivery was completed with ease, but PrEP was viewed as unnecessary. MP experience with the cascade corroborated AGYW perspectives and demonstrated how men can perceive female‐initiated HIV prevention options as beneficial for AGYW and a threat to MP masculinity.ConclusionsScreening to identify AGYW relationship dynamics can support tailoring prevention services to relationship‐driven barriers and facilitators. HIV prevention counseling for AGYW should address relationship goals or partner's influence, and engage with MP around female‐controlled prevention interventions.

AbstractNearly 75 percent of female sex workers (FSWs) in Port Elizabeth, South Africa are mothers, many of whom engage in sex work during pregnancy or after delivery. We conducted in‐depth interviews with 22 postpartum and 8 pregnant FSWs in Port Elizabeth. Interview guides were used to probe women's experiences, challenges, and concerns about selling sex during pregnancy and post‐delivery in a high‐HIV‐prevalence context. Interviews were transcribed, translated, and coded using thematic analysis. FSWs experienced and feared violence by clients during pregnancy, highlighting the need for safe work environments. Further, FSWs expressed concerns about HIV acquisition and vertical transmission during the perinatal period. Physical challenges related to pregnancy affected women's ability to work. Returning to work post‐delivery presented barriers to initiating and practicing exclusive breastfeeding. As a result, many FSWs practiced mixed feeding. Interventions, tailored to respond to FSW's challenges and experiences, may offer improved health outcomes in this context.

AbstractIntroductionKey populations bear a disproportionate HIV burden and have substantial unmet treatment needs. Routine viral load monitoring represents the gold standard for assessing treatment response at the individual and programme levels; at the population‐level, community viral load is a metric of HIV programme effectiveness and can identify "hotspots" of HIV transmission. Nevertheless, there are specific implementation and ethical challenges to effectively operationalize and meaningfully interpret viral load data at the community level among these often marginalized populations.DiscussionViral load monitoring enhances HIV treatment, and programme evaluation, and offers a better understanding of HIV surveillance and epidemic trends. Programmatically, viral load monitoring can provide data related to HIV service delivery coverage and quality, as well as inequities in treatment access and uptake. From a population perspective, community viral load data provides information on HIV transmission risk. Furthermore, viral load data can be used as an advocacy tool to demonstrate differences in service delivery and to promote allocation of resources to disproportionately affected key populations and communities with suboptimal health outcomes. However, in order to perform viral load monitoring for individual and programme benefit, health surveillance and advocacy purposes, careful consideration must be given to how such key population programmes are designed and implemented. For example, HIV risk factors, such as particular sex practices, sex work and drug use, are stigmatized or even criminalized in many contexts. Consequently, efforts must be taken so that routine viral load monitoring among marginalized populations does not cause inadvertent harm. Furthermore, given the challenges of reaching representative samples of key populations, significant attention to meaningful recruitment, decentralization of care and interpretation of results is needed. Finally, improving the interoperability of health systems through judicious use of biometrics or identifiers when confidentiality can be maintained is important to generate more valuable data to inform monitoring programmes.ConclusionsOpportunities for expanded viral load monitoring could and should benefit all those affected by HIV, including key populations. The promise of the increasing routinization of viral load monitoring as a tool to advance HIV treatment equity is great and should be prioritized and appropriately implemented within key population programmatic and research agendas.

AbstractIntroductionHealth‐related quality of life (HRQoL) is an important HIV outcome beyond viral suppression. However, there are limited data characterizing HRQoL of key populations, including female sex workers (FSW) living with HIV.MethodsWe used baseline data (22 June 2018–23 March 2020) of FSW who were diagnosed with HIV and enrolled into a randomized trial in Durban, South Africa. HRQoL information was collected by a generic preference‐accompanied tool with five domains (EQ‐5D), and summarized into a single score (range 0–1), which represents health utility. We employed multivariable beta regression models to identify determinants of HRQoL and to estimate subgroup‐specific HRQoL score. Using external estimates of life expectancy and population size, we estimated the number of quality adjusted life years reduced among FSW living with HIV in South Africa associated with violence and drug use.ResultsOf 1,363 individuals (mean age: 32.4 years; mean HRQoL score: 0.857) in our analysis, 62.6% used drugs, 61.3% experienced physical or sexual violence and 64.6% self‐reported taking antiretroviral treatment (ART). The following were associated with a reduction in the average marginal HRQoL score: older age (per decade: 0.018 [95% confidence interval (CI): 0.008, 0.027]), drug use (0.022 [0.007, 0.036]), experience of violence (0.024 [0.010, 0.038]) and moderate (vs. no) level of internalized stigma (0.023 [0.004, 0.041]). Current ART use was associated with a 0.015‐point (–0.001, 0.031) increase in the HRQoL score. The estimated mean (95% CI) HRQoL scores ranged from 0.838 (0.816, 0.860) for FSW who used drugs, experienced violence and were not on ART; to 0.899 (0.883, 0.916) for FSW who did not use drugs nor experience violence and were on ART. Our results can be translated into a reduction in 37,184 and 39,722 quality adjusted life years related to drug use and experience of violence, respectively, in South Africa.ConclusionsThese results demonstrate the association of ART with higher HRQoL among FSW and the need to further address structural risks, including drug use, violence and stigma. Population‐specific estimates of HRQoL score can be further used to calculate quality‐adjusted life years in economic evaluations of individual and structural interventions addressing the needs of FSW living with HIV.Clinical Trial RegistrationNCT03500172 (April 17, 2018).

AbstractIntroduction: Among men who have sex with men (MSM), men who sell sex (MSS) may be subject to increased sexual behaviour‐related stigma that affects uptake of healthcare and risk of sexually transmitted infections (STIs). The objectives of this study were to characterize stigma, access to care, and prevalence of HIV among MSS in Nigeria.Methods: Respondent‐driven sampling was used to recruit MSM in Abuja and Lagos into the ongoing TRUST/RV368 study, which provides HIV testing and treatment. Detailed behavioural data were collected by trained interviewers. MSS were identified by self‐report of receiving goods or money in exchange for sex with men. Poisson regression with robust error variance was used to explore the impact of sex‐selling on the risk of HIV.Results: From 12 initial seed participants, 1552 men were recruited from March 2013‐March 2016. Of these, 735 (47.4%) reported sex‐selling. Compared to other MSM, MSS were younger (median 22 vs. 24 years, p < 0.001) and more likely to identify as gay/homosexual (42.4% vs. 31.5%, p < 0.001). MSS were more likely to report perceived and experienced stigmas such as healthcare avoidance (27.6% vs. 21.5%, p = 0.005) and verbal harassment (39.2% vs. 26.8%, p < 0.001). Total HIV prevalence was 53.4%. After controlling for other factors, HIV prevalence among MSS was similar to that observed among other MSM (relative risk 0.94 [95% confidence interval 0.84–1.05]).Conclusions: These data highlight increased sexual behaviour‐related stigma affecting MSS, as compared with other MSM, that limits uptake of healthcare services. The distinct characteristics and risks among MSS suggest the need for specific interventions to optimize linkage to HIV prevention and treatment services in Nigeria.

AbstractIntroductionWhile disengagement from HIV care threatens the health of persons living with HIV (PLWH) and incidence‐reduction targets, re‐engagement is a critical step towards positive outcomes. Studies that establish a deeper understanding of successful return to clinical care among previously disengaged PLWH and the factors supporting re‐engagement are essential to facilitate long‐term care continuity.MethodsWe conducted narrative, patient‐centred, in‐depth interviews between January and June 2019 with 20 PLWH in Lusaka, Zambia, who had disengaged and then re‐engaged in HIV care, identified through electronic medical records (EMRs). We applied narrative analysis techniques, and deductive and inductive thematic analysis to identify engagement patterns and enablers of return.ResultsWe inductively identified five trajectories of care engagement, suggesting patterns in patient characteristics, experienced barriers and return facilitators that may aid intervention targeting including: (1) intermittent engagement;(2) mostly engaged; (3) delayed linkage after testing; (4) needs time to initiate antiretroviral therapy (ART); and (5) re‐engagement with ART initiation. Patient‐identified periods of disengagement from care did not always align with care gaps indicated in the EMR. Key, interactive re‐engagement facilitators experienced by participants, with varied importance across trajectories, included a desire for physical wellness and social support manifested through verbal encouragement, facility outreach or personal facility connections and family instrumental support. The mechanisms through which facilitators led to return were: (1) the promising of living out one's life priorities; (2) feeling valued; (3) fostering interpersonal accountability; (4) re‐entry navigation support; (5) facilitated care and treatment access; and (6) management of significant barriers, such as depression.ConclusionsWhile preliminary, the identified trajectories may guide interventions to support re‐engagement, such as offering flexible ART access to patients with intermittent engagement patterns instead of stable patients only. Further, for re‐engagement interventions to achieve impact, they must activate mechanisms underlying re‐engagement behaviours. For example, facility outreach that reminds a patient to return to care but does not affirm a patient's value or navigate re‐entry is unlikely to be effective. The demonstrated importance of positive health facility connections reinforces a growing call for patient‐centred care. Additionally, interventions should consider the important role communities play in fostering treatment motivation and overcoming practical barriers.

AbstractIntroductionIn 2016, South Africa (SA) initiated a national programme to scale‐up pre‐exposure prophylaxis (PrEP) among female sex workers (FSWs), with ∼20,000 PrEP initiations among FSWs (∼14% of FSW) by 2020. We evaluated the impact and cost‐effectiveness of this programme, including future scale‐up scenarios and the potential detrimental impact of the COVID‐19 pandemic.MethodsA compartmental HIV transmission model for SA was adapted to include PrEP. Using estimates on self‐reported PrEP adherence from a national study of FSW (67.7%) and the Treatment and Prevention for FSWs (TAPS) PrEP demonstration study in SA (80.8%), we down‐adjusted TAPS estimates for the proportion of FSWs with detectable drug levels (adjusted range: 38.0–70.4%). The model stratified FSW by low (undetectable drug; 0% efficacy) and high adherence (detectable drug; 79.9%; 95% CI: 67.2–87.6% efficacy). FSWs can transition between adherence levels, with lower loss‐to‐follow‐up among highly adherent FSWs (aHR: 0.58; 95% CI: 0.40–0.85; TAPS data). The model was calibrated to monthly data on the national scale‐up of PrEP among FSWs over 2016–2020, including reductions in PrEP initiations during 2020. The model projected the impact of the current programme (2016–2020) and the future impact (2021–2040) at current coverage or if initiation and/or retention are doubled. Using published cost data, we assessed the cost‐effectiveness (healthcare provider perspective; 3% discount rate; time horizon 2016–2040) of the current PrEP provision.ResultsCalibrated to national data, model projections suggest that 2.1% of HIV‐negative FSWs were currently on PrEP in 2020, with PrEP preventing 0.45% (95% credibility interval, 0.35–0.57%) of HIV infections among FSWs over 2016–2020 or 605 (444–840) infections overall. Reductions in PrEP initiations in 2020 possibly reduced infections averted by 18.57% (13.99–23.29). PrEP is cost‐saving, with $1.42 (1.03–1.99) of ART costs saved per dollar spent on PrEP. Going forward, existing coverage of PrEP will avert 5,635 (3,572–9,036) infections by 2040. However, if PrEP initiation and retention doubles, then PrEP coverage increases to 9.9% (8.7–11.6%) and impact increases 4.3 times with 24,114 (15,308–38,107) infections averted by 2040.ConclusionsOur findings advocate for the expansion of PrEP to FSWs throughout SA to maximize its impact. This should include strategies to optimize retention and should target women in contact with FSW services.

AbstractIntroductionTracing patients lost to follow‐up (LTFU) from HIV care is widely practiced, yet we have little knowledge of its causal effect on care engagement. In a prospective, Zambian cohort, we examined the effect of tracing on return to care within 2 years of LTFU.MethodsWe traced a stratified, random sample of LTFU patients who had received HIV care between August 2013 and July 2015. LTFU was defined as a gap of >90 days from last scheduled appointment in the routine electronic medical record. Extracting 2 years of follow‐up visit data through 2017, we identified patients who returned. Using random selection for tracing as an instrumental variable (IV), we used conditional two‐stage least squares regression to estimate the local average treatment effect of tracer contact on return. We examined the observational association between tracer contact and return among patient sub‐groups self‐confirmed as disengaged from care.ResultsOf the 24,164 LTFU patients enumerated, 4380 were randomly selected for tracing and 1158 were contacted by a tracer within a median of 14.8 months post‐loss. IV analysis found that patients contacted by a tracer because they were randomized to tracing were no more likely to return than those not contacted (adjusted risk difference [aRD]: 3%, 95% CI: –2%, 8%, p = 0.23). Observational data showed that among contacted, disengaged patients, the rate of return was higher in the week following tracer contact (IR 5.74, 95% CI: 3.78–8.71) than in the 2 weeks to 1‐month post‐contact (IR 2.28, 95% CI: 1.40–3.72). There was a greater effect of tracing among patients lost for >6 months compared to those contacted within 3 months of loss.ConclusionsOverall, tracer contact did not causally increase LTFU patient return to HIV care, demonstrating the limited impact of tracing in this program, where contact occurred months after patients were LTFU. However, observational data suggest that tracing may speed return among some LTFU patients genuinely out‐of‐care. Further studies may improve tracing effectiveness by examining the mechanisms underlying the impact of tracing on return to care, the effect of tracing at different times‐since‐loss and using more accurate identification of patients who are truly disengaged to target tracing.

AbstractIntroductionPerson‐centred care (PCC) has been recognized as a critical element in delivering quality and responsive health services. The patient−provider relationship, conceptualized at the core of PCC in multiple models, remains largely unexamined in HIV care. We conducted a systematic review to better understand the types of PCC interventions implemented to improve patient−provider interactions and how these interventions have improved HIV care continuum outcomes and person‐reported outcomes (PROs) among people living with HIV in low‐ and middle‐income countries.MethodsWe searched databases, conference proceedings and conducted manual targeted searches to identify randomized trials and observational studies published up to January 2023. The PCC search terms were guided by the Integrative Model of Patient‐Centeredness by Scholl. We included person‐centred interventions aiming to enhance the patient−provider interactions. We included HIV care continuum outcomes and PROs.ResultsWe included 28 unique studies: 18 (64.3%) were quantitative, eight (28.6.%) were mixed methods and two (7.1%) were qualitative. Within PCC patient−provider interventions, we inductively identified five categories of PCC interventions: (1) providing friendly and welcoming services; (2) patient empowerment and improved communication skills (e.g. supporting patient‐led skills such as health literacy and approaches when communicating with a provider); (3) improved individualized counselling and patient‐centred communication (e.g. supporting provider skills such as training on motivational interviewing); (4) audit and feedback; and (5) provider sensitisation to patient experiences and identities. Among the included studies with a comparison arm and effect size reported, 62.5% reported a significant positive effect of the intervention on at least one HIV care continuum outcome, and 100% reported a positive effect of the intervention on at least one of the included PROs.DiscussionAmong published HIV PCC interventions, there is heterogeneity in the components of PCC addressed, the actors involved and the expected outcomes. While results are also heterogeneous across clinical and PROs, there is more evidence for significant improvement in PROs. Further research is necessary to better understand the clinical implications of PCC, with fewer studies measuring linkage or long‐term retention or viral suppression.ConclusionsImproved understanding of PCC domains, mechanisms and consistency of measurement will advance PCC research and implementation.