Opportunities and Challenges to Emergency Department-Based HIV Testing Services and Self-Testing Programs: A Qualitative Study of Healthcare Providers and Patients in Kenya

BACKGROUND: Young people in Sub-Saharan Africa, especially males, have been insufficiently engaged through HIV Testing Services (HTS). In Kenya, younger persons are often treated in emergency departments (EDs) for injuries, an interaction where HTS and HIV self-testing (HIVST) can be leveraged. Data from stakeholders on ED-HTS and HIVST is lacking and needed to understand opportunities and barriers for HIV testing and care, and inform program implementation. METHODS: Between December 2021 and March 2022, 32 in-depth interviews (IDIs) were conducted with 16 male and 16 female patients who had been treated in the Kenyatta National Hospital (KNH) ED, half of whom had been HIV-tested. Six focus-group discussions (FGDs) were also conducted with 50 nurses, doctors, HIV testing counselors, and administrators working in the ED. All transcripts were double-coded and thematically analyzed using Dedoose software and a parallel inductive and deductive coding approach which allowed for capture of both a priori and emergent themes. RESULTS: Patients and providers agreed that ED-HTS are facilitated by friendly staff, patient education, high perceived HIV risk, and confidentiality. However, ED-HTS is limited by burdens on staff, resources, time, and space, as well as severity of patient injuries limiting ability to consent to or prioritize HIV testing. These limitations provide opportunities for ED-HIVST: particularly the ability to test at a comfortable time and place, especially when provided alongside sufficient HIV and testing education, contact with healthcare providers, and psychosocial support. Barriers for ED-HIVST where identified and as patients’ concerns about HIVST accuracy and mental health impacts of a positive test, as well providers’ identified barriers on their concerns for loss to follow up and inability to complete confirmatory testing. COM-B Model [Figure: see text] Application of the COM-B Model of Behavior Change to ED-HIVST Acceptability in Kenya CONCLUSION: ED stakeholders are receptive to HTS and HIVST, and patients desire the opportunity to use HIVST. Potential challenges—such as psychological effects of testing positive, worries about access to follow-up care, and confusion about how to self-administer testing, may be addressed through programming designed to promote education, access and ensure follow-up mechanisms. DISCLOSURES: All Authors: No reported disclosures

Implications of gestational age at antenatal care attendance on the successful implementation of a maternal respiratory syncytial virus (RSV) vaccine program in coastal Kenya

Background: Maternal immunisation to boost respiratory syncytial virus (RSV) specific antibodies in pregnant women is a strategy to enhance infant protection. The timing of maternal vaccination during pregnancy may be critical for its effectiveness. However, Kenya has no documented published data on gestational age distribution of pregnant women attending antenatal care (ANC), or the proportion of women attending ANC during the proposed window period for vaccination, to inform appropriate timing for delivery or estimate potential uptake of this vaccine. Methods: A cross-sectional survey was conducted within the Kilifi Health and Demographic Surveillance System (KHDSS), coastal Kenya. A simple random sample of 1000 women who had registered pregnant in 2017 to 2018 and with a birth outcome by the time of data collection was taken. The selected women were followed at their homes, and individually written informed consent was obtained. Records of their antenatal attendance during pregnancy were abstracted from their ANC booklet. The proportion of all pregnant women from KHDSS (55%) who attended for one or more ANC in 2018 was used to estimate vaccine coverage. Results: Of the 1000 women selected, 935 were traced with 607/935 (64.9%) available for interview, among whom 470/607 (77.4%) had antenatal care booklets. The median maternal age during pregnancy was 28.6 years. The median (interquartile range) gestational age in weeks at the first to fifth ANC attendance was 26 (21–28), 29 (26–32), 32 (28–34), 34 (32–36) and 36 (34–38), respectively. The proportion of women attending for ANC during a gestational age window for vaccination of 28–32 weeks (recommended), 26–33 weeks and 24–36 weeks was 76.6% (360/470), 84.5% (397/470) and 96.2% (452/470), respectively. Estimated vaccine coverage was 42.1, 46.5 and 52.9% within the narrow, wide and wider gestational age windows, respectively. Conclusions: In a random sample of pregnant women from Kilifi HDSS, Coastal Kenya with card-confirmed ANC clinic attendance, 76.6% would be reached for maternal RSV vaccination within the gestational age window of 28–32 weeks. Widening the vaccination window (26–33 weeks) or (24–36 weeks) would not dramatically increase vaccine coverage and would require consideration of antibody kinetics data that could affect vaccine efficacy

Usability and acceptability of oral fluid hepatitis C self-testing among people who inject drugs in Coastal Kenya: a cross-sectional pilot study.

BACKGROUND: People who inject drugs (PWID) are disproportionally affected by hepatitis C virus (HCV) infection and many remain undiagnosed. HCV self-testing (HCVST) may be an effective approach to increase testing uptake, but has rarely been used among PWID. We assessed the usability and acceptability of HCVST among PWID in Kenya. METHODS: We conducted a cross-sectional study nested within a cohort study between August and December 2020 on Kenya's North Coast region. Participants were handed a prototype oral fluid HCVST kit and asked to conduct the test relying on the instructions for use. Usability was assessed by documenting errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. RESULTS: Among 150 participants, 19% were female and 65.3% had primary level education or lower. 71.3% made at least one error, 56.7% experienced some difficulty during at least one step, and the majority of participants (78%) required assistance during at least one step of the procedure. Most common errors occurred when placing the tube into the stand (18%), collecting the oral fluid sample (24%) and timing of reading results (53%). There was a strong association between presence of symptoms of opiate withdrawals and observed errors (94% vs 62%; p = 0.016) in a sub-group of 74 participants assessed. Inter-reader and inter-operator concordance were 97.7% (kappa: 0.92) and 99.2% (kappa: 0.95), respectively. Acceptability assessed by asking whether participants would choose to use HCVST prior to and after conducting HCVST was 98% and 95%, respectively. CONCLUSIONS: We found a high acceptability of oral fluid HCVST among PWID. User errors were common and were associated with the presence of withdrawal symptoms among users. Despite errors, most participants were able to obtain and interpret results correctly. These findings suggest that this group of users may benefit from greater messaging and education including options to receive direct assistance when self-testing for HCV

Assisted partner notification services to augment HIV testing and linkage to care in Kenya: study protocol for a cluster randomized trial

Background: HIV case-finding and linkage to care are critical for control of HIV transmission. In Kenya, >50% of seropositive individuals are unaware of their status. Assisted partner notification is a public health strategy that provides HIV testing to individuals with sexual exposure to HIV and are at risk of infection and disease. This parallel, cluster-randomized controlled trial will evaluate the effectiveness, cost-effectiveness, and feasibility of implementing HIV assisted partner notification services at HIV testing sites (clusters) in Kenya. Methods/design Eighteen sites were selected among health facilities in Kenya with well-established, high-volume HIV testing programs, to reflect diverse communities and health-care settings. Restricted randomization was used to balance site characteristics between study arms (n = 9 per arm). Sixty individuals testing HIV positive (‘index partners’) will be enrolled per site (inclusion criteria: ≥18 years, positive HIV test at a study site, willing to disclose sexual partners, and never enrolled for HIV care; exclusion criteria: pregnancy or high risk of intimate partner violence). Index partners provide names and contact information for all sexual partners in the past 3 years. At intervention sites, study staff immediately contact sexual partners to notify them of exposure, offer HIV testing, and link to care if HIV seropositive. At control sites, passive partner referral is performed according to national guidelines, and assisted partner notification is delayed by 6 weeks. Primary outcomes, assessed 6 weeks after index partner enrollment and analyzed at the cluster level, are the number of partners accepting HIV testing and number of HIV infections diagnosed and linked to care per index partner. Secondary outcomes are the incremental cost-effectiveness of partner notification and the costs of identifying >1 partner per index case. Participants are closely monitored for adverse outcomes, particularly intimate partner violence. The study is unblinded due to practical limitations. Discussion This rigorously designed trial will inform policy decisions regarding implementation of HIV partner notification services in Kenya, with possible application to other parts of sub-Saharan Africa. Examination of effectiveness and cost-effectiveness in diverse settings will enable targeted application and define best practices. Trial registration ClinicalTrials.gov NCT01616420

Regional Differences in Prevalence of HIV-1 Discordance in Africa and Enrollment of HIV-1 Discordant Couples into an HIV-1 Prevention Trial

Background: Most HIV-1 transmission in Africa occurs among HIV-1-discordant couples (one partner HIV-1 infected and one uninfected) who are unaware of their discordant HIV-1 serostatus. Given the high HIV-1 incidence among HIV-1 discordant couples and to assess efficacy of interventions for reducing HIV-1 transmission, HIV-1 discordant couples represent a critical target population for HIV-1 prevention interventions and prevention trials. Substantial regional differences exist in HIV-1 prevalence in Africa, but regional differences in HIV-1 discordance among African couples, has not previously been reported. Methodology/Principal Findings: The Partners in Prevention HSV-2/HIV-1 Transmission Trial (“Partners HSV-2 Study”), the first large HIV-1 prevention trial in Africa involving HIV-1 discordant couples, completed enrollment in May 2007. Partners HSV-2 Study recruitment data from 12 sites from East and Southern Africa were used to assess HIV-1 discordance among couples accessing couples HIV-1 counseling and testing, and to correlate with enrollment of HIV-1 discordant couples. HIV-1 discordance at Partners HSV-2 Study sites ranged from 8–31% of couples tested from the community. Across all study sites and, among all couples with one HIV-1 infected partner, almost half (49%) of couples were HIV-1 discordant. Site-specific monthly enrollment of HIV-1 discordant couples into the clinical trial was not directly associated with prevalence of HIV-1 discordance, but was modestly correlated with national HIV-1 counseling and testing rates and access to palliative care/basic health care (r = 0.74, p = 0.09). Conclusions/Significance: HIV-1 discordant couples are a critical target for HIV-1 prevention in Africa. In addition to community prevalence of HIV-1 discordance, national infrastructure for HIV-1 testing and healthcare delivery and effective community outreach strategies impact recruitment of HIV-1 discordant couples into HIV-1 prevention trials

Antiretroviral Drugs Protect Against HIV-1 Infection in Heterosexuals

BackgroundAntiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations.MethodsWe conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens--once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo--and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services.ResultsWe enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF-FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF-FTC and TDF alone against HIV-1 were not significantly different (P=0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the study.ConclusionsOral TDF and TDF-FTC both protect against HIV-1 infection in heterosexual men and women. (Funded by the Bill and Melinda Gates Foundation; Partners PrEP ClinicalTrials.gov number, NCT00557245.)

Plasma viral loads during early HIV-1 infection are similar in subtype C- and non-subtype C-infected African seroconverters.

Recent data suggest that infection with human immunodeficiency virus type 1 (HIV-1) subtype C results in prolonged high-level viremia (>5 log10 copies/mL) during early infection. We examined the relationship between HIV-1 subtype and plasma viremia among 153 African seroconverters. Mean setpoint viral loads were similar for C and non-C subtypes: 4.36 vs 4.42 log10 copies/mL (P = .61). The proportion of subtype C-infected participants with viral loads >5 log10 copies/mL was not greater than the proportion for those with non-C infection. Our data do not support the hypothesis that higher early viral load accounts for the rapid spread of HIV-1 subtype C in southern Africa

Women and ARVâ based prevention: opportunities and challenges

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/138349/1/jia29419.pd

Characteristics of HIV-1 Discordant Couples Enrolled in a Trial of HSV-2 Suppression to Reduce HIV-1 Transmission: The Partners Study

Background: The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort. Methods: HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count ≥250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed. Results: Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2–9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (500 relative to <350, respectively, p<0.001). Conclusions: The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission. Trial Registration ClinicalTrials.gov NCT0019451