Suchergebnisse

BackgroundObservational HIV clinic databases are now widely used to answer key questions related to HIV care and treatment, but there has been no systematic evaluation of their quality of data. Our objective was to evaluate the completeness and accuracy of recording of key data HIV items in a large routine observational HIV clinic database.MethodsWe looked at the number and rate of opportunistic infections (OIs) per 100 person years at risk in the 24 months following antiretroviral therapy (ART) initiation in 559 patients who initiated ART in 2004‐2005 and enrolled into a research cohort. We compared this with data in a routine clinic database for the same 559 patients, and a further 1233 patients who initiated ART in the same period. The Research Cohort database was considered as the reference "gold standard" for the assessment of data accuracy. A crude percentage of underreporting of OIs in the clinic database was calculated based on the difference between the OI rates reported in both databases.We reviewed 100 clinic patient medical records to assess the accuracy of recording of key data items of OIs, ART toxicities and ART regimen changes.ResultsThe overall incidence rate per 100 person years at risk for the initial OI in the 559 patients in the research cohort and clinic databases was 24.1 (95% CI: 20.5‐28.2) and 13.2 (95% CI: 10.8‐16.2) respectively, and 10.4 (95% CI: 9.1‐11.9) for the 1233 clinic patients. This represents a 1.8‐ and 2.3‐fold higher rate of events in the research cohort database compared with the same 599 patients and 1233 patients in the routine clinic database, or a 45.1% and 56.8% rate of underreporting, respectively. The combined error rate of missing and incorrect items from the medical records' review was 67% for OIs, 52% for ART‐related toxicities, and 83% and 58% for ART discontinuation and modification, respectively.ConclusionsThere is a high rate of underreporting of OIs in a routine HIV clinic database. This has important implications for the use and interpretation of routine observational databases for research and audit, and highlights the need for regular data validation of these databases.

Abstract
Background
Diabetes and hypertension are increasingly prevalent in low and middle income countries, but they are not well documented in refugee settlements in these settings. We sought to estimate the prevalence and associated characteristics of diabetes and hypertension among adults presenting for clinic-based HIV testing in Nakivale Refugee Settlement in Uganda.

Methods
HIV-negative adults presenting to outpatient clinics for HIV testing at three health centers in Nakivale Refugee Settlement were enrolled from January 2019 through January 2020. Multi-lingual research assistants administered questionnaires aloud to ascertain medical history and sociodemographic information. The research assistants used standardized procedures to measure participants' blood pressure to detect hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg), and conduct a point-of-care blood glucose test for diabetes (random blood glucose ≥11.1 mmol/L with self-reported frequent urination or thirst, or fasting blood glucose ≥7.0 mmol/L regardless of symptoms), as per Uganda Ministry of Health guidelines. We used χ-square or Fisher's exact test to test for differences in disease prevalence by refugee status and log-binomial or Poisson regression models to estimate associations of immigration status and country of origin, respectively, with hypertension and diabetes while controlling for age, sex, education level, and body mass index.

Results
Among 2127 participants, 1379 (65%) were refugees or asylum seekers and 748 (35%) were Ugandan nationals. Overall, 32 participants met criteria for diabetes (1.5%, 95% CI 1.1–2.1%) and the period prevalence was 2.3% (95% CI 1.7–3.0). There were 1067 (50%, 95% CI 48.0–52.2%) who met the criteria for pre-hypertension and 189 (9%, 95% CI 7.7–10.1%) for hypertension. These proportions did not vary by immigration status or country of origin in univariate tests or multivariable regression models.

Conclusions
Hypertension was common and diabetes was uncommon among those screened in a Ugandan refugee settlement. Routine blood pressure screening should be considered in this setting. Additional research could develop diabetes screening criteria to help identify at risk individuals in this limited resource setting.

AbstractIntroductionPre‐exposure prophylaxis (PrEP) to prevent HIV infection is being rolled out in Africa. The uptake of PrEP to date has varied across populations and locations. We seek to understand the drivers of demand for PrEP through analysis of qualitative data collected in conjunction with a PrEP demonstration project involving East African HIV serodiscordant couples. Our goal was to inform demand creation by understanding what PrEP means – beyond HIV prevention – for the lives of users.MethodsThe Partners Demonstration Project evaluated an integrated strategy of PrEP and antiretroviral therapy (ART) delivery in which time‐limited PrEP served as a "bridge" to long‐term ART. Uninfected partners in HIV serodiscordant couples were offered PrEP at baseline and encouraged to discontinue once infected partners had taken ART for six months. We conducted 274 open‐ended interviews with 93 couples at two Ugandan research sites. Interviews took place one month after enrolment and at later points in the follow‐up period. Topics included are as follows: (1) discovery of serodiscordance; (2) decisions to accept/decline PrEP and/or ART; (3) PrEP and ART initiation; (4) experiences of using PrEP and ART; (5) PrEP discontinuation; (6) impact of PrEP and ART on the partnered relationship. Interviews were audio‐recorded and transcribed. We used an inductive, content analytic approach to characterize meanings of PrEP stemming from its effectiveness for HIV prevention. Relevant content was represented as descriptive categories.ResultsDiscovery of HIV serodiscordance resulted in fear of HIV transmission for couples, which led to loss of sexual intimacy in committed relationships, and to abandonment of plans for children. As a result, partners became alienated from each other. PrEP countered the threat to the relationship by reducing fear and reinstating hopes of having children together. Condom use worked against the re‐establishment of intimacy and closeness. By increasing couples' sense of protection against HIV infection and raising the prospect of a return to "live sex" (sex without condoms), PrEP was perceived by couples as solving the problem of serodiscordance and preserving committed relationships.ConclusionsThe most effective demand creation strategies for PrEP may be those that address the everyday life priorities of potential users in addition to HIV prevention.Clinical Trial NumberNCT02775929

AbstractIntroductionHIV self‐testing (HIVST) and oral pre‐exposure prophylaxis (PrEP) are complementary, evidence‐based, self‐controlled HIV prevention tools that may be particularly appealing to sex workers. Understanding how HIVST and PrEP are perceived and used by sex workers and their intimate partners could inform prevention delivery for this population. We conducted qualitative interviews to examine ways in which HIVST and PrEP use influence prevention choices among sex workers in Uganda.MethodsWithin a randomized trial of HIVST and PrEP among 110 HIV‐negative cisgender women, cisgender men and transgender women sex workers (NCT03426670), we conducted 40 qualitative interviews with 30 sex workers and 10 intimate partners (June 2018 to January 2020). Sex worker interviews explored (a) experiences of using HIVST kits; (b) how HIVST was performed with sexual partners; (c) impact of HIVST on PrEP pill taking; and (d) sexual risk behaviours after HIVST. Partner interviews covered (i) introduction of HIVST; (ii) experiences of using HIVST; (iii) HIV status disclosure; and (iv) HIVST's effect on sexual behaviours. Data were analysed using an inductive content analytic approach centering on descriptive category development. Together, these categories detail the meaning of HIVST and PrEP for these qualitative participants.ResultsUsing HIVST and PrEP was empowering for this group of sex workers and their partners. Three types of empowerment were observed: (a) economic; (b) relational; and (c) sexual health. (i) Using HIVST and PrEP made sex without condoms safer. Sex workers could charge more for condomless sex, which was empowering economically. (ii) Self‐testing restored trust in partners' fidelity upon being reunited after a separation. This trust, in combination with condomless sex made possible by PrEP use, restored intimacy, empowering partnered relationships. (iii) HIVST and PrEP enabled sex workers to take control of their HIV prevention efforts and avoid the stigma of public clinic visits. In this way they were empowered to protect their sexual health.ConclusionsIn this sample, sex workers' use of HIVST and PrEP benefitted not only prevention efforts, but also economic and relational empowerment. Understanding these larger benefits and communicating them to stakeholders could strengthen uptake and use of combination prevention interventions in this marginalized population.

AbstractIntroductionSerodiscordant couples are a priority population for delivery of newHIVprevention interventions in Africa. An integrated strategy of delivering time‐limited, oral pre‐exposure prophylaxis (PrEP) to uninfected partners in serodiscordant couples as a bridge to long‐term antiretroviral treatment (ART) for infected partners has been implemented in East Africa, nearly eliminating new infections. We conducted a qualitative evaluation of the integrated strategy in Uganda, to better understand its success.MethodsData collection consisted of 274 in‐depth interviews with 93 participating couples, and 55 observations of clinical encounters between couples and healthcare providers. An inductive content analytic approach aimed at understanding and interpreting couples' experiences of the integrated strategy was used to examine the data. Analysis sought to characterize: (1) key aspects of services provided; (2) what the services meant to recipients; and (3) how couples managed the integrated strategy. Themes were identified in each domain, and represented as descriptive categories. Categories were grouped inductively into more general propositions based on shared content. Propositions were linked and interpreted to explain "why the integrated strategy worked."ResultsCouples found "couples‐focused" services provided through the integrated strategy strengthened partnered relationships threatened by the discovery of serodiscordance. They saw in services hope for "getting help" to stay together, turned joint visits to clinic into opportunities for mutual support, and experienced counselling as bringing them closer together.Couples adopted a "couples orientation" to the integrated strategy, considering the health of partners as they made decisions about initiatingARTor accepting PrEP, and devising joint approaches to adherence. A couples orientation to services, grounded in strengthened partnerships, may have translated to greater success in using antiretrovirals to preventHIVtransmission.ConclusionsVarious strategies for delivering antiretrovirals forHIVprevention are being evaluated. Understanding how and why these strategies work will improve evaluation processes and strengthen implementation platforms. We highlight the role of service organization in shaping couples' experiences of and responses toARTand PrEPin the context of the integrated strategy. Organizing services to promote positive care experiences will strengthen delivery and contribute to positive outcomes as antiretrovirals for prevention are rolled out.

AbstractIntroductionAdherence counselling with point‐of‐care (POC) drug‐level feedback using a novel tenofovir assay may support pre‐exposure prophylaxis (PrEP) adherence; however, perceptions of urine testing and its impact on adherence are not well studied. We qualitatively examined how POC tenofovir testing was experienced by transgender women (TGW) in Uganda.MethodsWithin a cluster randomized trial of peer‐delivered HIV self‐testing, self‐sampling for sexually transmitted infections and PrEP among HIV‐negative TGW showing overall low PrEP prevention‐effective adherence (NCT04328025), we conducted a nested qualitative sub‐study of the urine POC assay among a random sample of 30 TGW (August 2021−February 2022). TGW interviews explored: (1) experiences with POC urine tenofovir testing and (2) perceptions of PrEP adherence counselling with drug‐level feedback. We used an inductive content analytic approach for analysis.ResultsMedian age was 21 years (interquartile range 20–24), and 70% engaged in sex work. Four content categories describe how TGW experienced POC urine tenofovir testing: (1) Urine tenofovir testing was initially met with scepticism: Testing urine to detect PrEP initially induced anxiety, with some perceptions of being intrusive and unwarranted. With counselling, however, participants found POC testing acceptable and beneficial. (2) Alignment of urine test results and adherence behaviours: Drug‐level feedback aligned with what TGW knew about their adherence. Concurrence between pill taking and tenofovir detection in urine reinforced confidence in test accuracy. (3) Interpretation of urine tenofovir results: TGW familiar with the interpretation of oral‐fluid HIV self‐tests knew that two lines on the test device signified positivity (presence of HIV). However, two lines on the urine test strip indicated a positive result for non‐adherence (absence of tenofovir), causing confusion. Research nurses explained the difference in test interpretation to participants' satisfaction. (4) White coat dosing: Some TGW deliberately chose not to attend scheduled clinic appointments to avoid detecting their PrEP non‐adherence during urine testing. They restarted PrEP before returning to clinic, a behaviour called "white coat dosing."ConclusionsIncorporating POC urine testing into routine PrEP adherence counselling was acceptable and potentially beneficial for TGW but required attention to context. Additional research is needed to identify effective strategies for optimizing adherence monitoring and counselling for this population.

AbstractIntroductionSecondary distribution of HIV self‐tests (HIVST) by HIV‐negative pregnant women to male partners increases men's testing rates. We examined whether this strategy promotes male partner testing for pregnant women living with HIV (PWLHIV).MethodsWe conducted an open‐label individually randomized trial in Kampala, Uganda, in which PWLHIV ≥18 years who reported a partner of unknown HIV status were randomized 2:1 to secondary distribution of HIVST for male partner(s) or standard‐of‐care (SOC; invitation letter to male partner for fast‐track testing). Women were followed until 12 months post‐partum. Male partners were offered confirmatory HIV testing and facilitated linkage to antiretroviral treatment (ART) or oral pre‐exposure prophylaxis (PrEP). Using intention‐to‐treat analysis, primary outcomes were male partner testing at the clinic and initiation on PrEP or ART evaluated through 12 months post‐partum (ClinicalTrials.gov, NCT03484533).ResultsFrom November 2018 to March 2020, 500 PWLHIV were enrolled with a median age of 27 years (interquartile range [IQR] 23–30); 332 were randomized to HIVST and 168 to SOC with 437 PWLHIV (87.4%) completing 12 months follow‐up post‐partum. Of 236 male partners who tested at the clinic and enrolled (47.2%), their median age was 31 years (IQR 27–36), 45 (88.3%) men with HIV started ART and 113 (61.1%) HIV‐negative men started PrEP. There was no intervention effect on male partner testing (hazard ratio [HR] 1.04; 95% confidence interval [CI]: 0.79–1.37) or time to ART or PrEP initiation (HR 0.96; 95% CI: 0.69–1.33). Two male partners and two infants acquired HIV for an incidence of 0.99 per 100 person‐years (95% CI: 0.12–3.58) and 1.46 per 100 person‐years (95% CI: 0.18%–5.28%), respectively. Social harms related to study participation were experienced by six women (HIVST = 5, SOC = 1).ConclusionsAlmost half of the partners of Ugandan PWLHIV tested for HIV with similar HIV testing rates and linkage to ART or PrEP among the secondary distribution of HIVST and SOC arms. Although half of men became aware of their HIV serostatus and linked to services, additional strategies to reach male partners of women in antenatal care are needed to increase HIV testing and linkage to services among men.

AbstractIntroductionPeer delivery is a client‐centred approach that could maximize the coverage and impact of HIV services for transgender women (TGW). We conducted qualitative interviews to examine how peer‐delivered HIV self‐testing (HIVST), sexually transmitted infection self‐sampling (STISS) and oral pre‐exposure prophylaxis (PrEP) influenced prevention choices among TGW and their intimate partners in Uganda.MethodsWithin a cluster randomized trial of peer‐delivered HIVST, STISS and PrEP among HIV‐negative TGW (NCT04328025), we conducted 55 qualitative interviews with 30 TGW, 15 intimate partners and 10 TGW peers (August 2021–February 2022). TGW interviews explored: (1) HIV self‐test and PrEP experiences; (2) HIVST with intimate partners; and (3) descriptions of self‐sampling for STI testing. Partner interviews covered: (1) experiences with HIVST; (2) disclosure of HIV status to intimate partner; and (3) descriptions of sexual behaviours after testing. Peer interview topics included: (1) intervention delivery experiences; and (2) recommendations for peer‐delivered HIV prevention services to TGW, including psychological support and coping strategies. Qualitative data were analysed using an inductive content analytic approach.ResultsPeer‐delivered combination prevention was valued by this group of TGW and their partners. (1) Peer services extended beyond delivering HIV/STI kits and PrEP refills to caring for individual health and wellbeing by providing stigma coping strategies. Peer psychosocial support empowered research participants to become "HIVST ambassadors," teach non‐study TGW about self‐testing and PrEP, and encourage linkage to care. (2) HIVST with intimate partners and mutual disclosure of HIV status strengthened partnered relationships. PrEP use after both partners tested HIV negative implied infidelity. (3) Self‐sampling enabled TGW to take control of their STI testing and avoid the embarrassment of exposing their bodies. Privacy and confidentiality motivated the uptake of STI testing and treatment.ConclusionsIn this sample of TGW from Uganda, peer delivery of HIVST, STISS and PrEP refills benefitted individual prevention efforts and extended to a new linkage of TGW not engaged in care. Integrating peer services into differentiated PrEP delivery could increase HIV/STI test coverage and PrEP use in this vulnerable population.

AbstractIntroductionTransgender (trans) men in sub‐Saharan Africa are a hidden and vulnerable population who may engage in sex work due to socio‐economic exclusion and lack of alternative employment opportunities. Little is known about HIV and sexually transmitted infection (STI) risk among trans men in this setting. We conducted a multi‐method study to characterize HIV/STI risk among trans men in Uganda.MethodsBetween January and October 2020, we enrolled 50 trans men into a cross‐sectional study through snowball sampling. Data were collected on socio‐demographic characteristics, sexual practices and depression. We conducted 20 qualitative interviews to explore: (1) descriptions of sexual practices that could increase HIV/STI exposure; (2) experiences of accessing public healthcare facilities; (3) perceptions of HIV or STI testing; (4) HIV and STI service delivery; and (5) drug and alcohol use. We used an inductive content analytic approach centring on descriptive category development to analyse the data.ResultsThe median age was 25 years (interquartile range 23–28). The prevalence of HIV, syphilis and hepatitis B was 4%, 6% and 8%, respectively. We observed multiple levels of intersecting individual, interpersonal and structural stigmas. (1) Trans men reported transphobic rape motivated by interpersonal stigma that was psychologically traumatizing to the survivor. The resultant stigma and shame hindered healthcare access. (2) Structural stigma and economic vulnerability led to sex work, which increased the risk of HIV and other STIs. Sex work stigma further compounded vulnerability. (3) Individualized stigma led to fear of disclosure of gender identity and HIV status. Concealment was used as a form of stigma management. (4) Multiple levels of stigma hampered access to healthcare services. Preference for trans‐friendly care was motivated by stigma avoidance in public facilities. Overall, the lived experiences of trans men highlight the intertwined relationship between stigma and sexual health.ConclusionsIn this sample from Uganda, trans men experienced stigma at multiple levels, highlighting the need for gender‐sensitive healthcare delivery. Stigma reduction interventions, including provider training, non‐discrimination policies, support groups and stigma counselling, could strengthen uptake and utilization of prevention services by this marginalized population.