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

ABSTRACT: 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.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.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.ClinicalTrials.gov NCT01616420 .

SUBMITTER: Wamuti BM

PROVIDER: S-EPMC4342094 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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

Wamuti Beatrice Muthoni BM Erdman Laura Kelly LK Cherutich Peter P Golden Matthew M Dunbar Matthew M Bukusi David D Richardson Barbra B Ng'ang'a Anne A Barnabas Ruanne R Mutiti Peter Maingi PM Macharia Paul P Jerop Mable M Otieno Felix Abuna FA Poole Danielle D Farquhar Carey C

Implementation science : IS 20150213

<h4>Background</h4>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 ...[more]

PMID: 25884936

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Project description:BackgroundAssisted partner services for index patients with HIV infections involves elicitation of information about sex partners and contacting them to ensure that they test for HIV and link to care. Assisted partner services are not widely available in Africa. We aimed to establish whether or not assisted partner services increase HIV testing, diagnoses, and linkage to care among sex partners of people with HIV infections in Kenya.MethodsIn this cluster randomised controlled trial, we recruited non-pregnant adults aged at least 18 years with newly or recently diagnosed HIV without a recent history of intimate partner violence who had not yet or had only recently linked to HIV care from 18 HIV testing services clinics in Kenya. Consenting sites in Kenya were randomly assigned (1:1) by the study statistician (restricted randomisation; balanced distribution in terms of county and proximity to a city) to immediate versus delayed assisted partner services. Primary outcomes were the number of partners tested for HIV, the number who tested HIV positive, and the number enrolled in HIV care, in those who were interviewed at 6 week follow-up. Participants within each cluster were masked to treatment allocation because participants within each cluster received the same intervention. This trial is registered with ClinicalTrials.gov, number NCT01616420.FindingsBetween Aug 12, 2013, and Aug 31, 2015, we randomly allocated 18 clusters to immediate and delayed HIV assisted partner services (nine in each group), enrolling 1305 participants: 625 (48%) in the immediate group and 680 (52%) in the delayed group. 6 weeks after enrolment of index patients, 392 (67%) of 586 partners had tested for HIV in the immediate group and 85 (13%) of 680 had tested in the delayed group (incidence rate ratio 4·8, 95% CI 3·7-6·4). 136 (23%) partners had new HIV diagnoses in the immediate group compared with 28 (4%) in the delayed group (5·0, 3·2-7·9) and 88 (15%) versus 19 (3%) were newly enrolled in care (4·4, 2·6-7·4). Assisted partner services did not increase intimate partner violence (one intimate partner violence event related to partner notification or study procedures occurred in each group).InterpretationAssisted partner services are safe and increase HIV testing and case-finding; implementation at the population level could enhance linkage to care and antiretroviral therapy initiation and substantially decrease HIV transmission.FundingNational Institutes of Health.

Project description:INTRODUCTION:We have previously demonstrated that assisted partner services (aPS) increases HIV testing and case finding among partners of persons living with HIV (PLHIV) in a cluster randomized trial in Kenya. However, the efficacy of aPS may vary across populations. In this analysis, we explore differences in aPS efficacy by characteristics of index participants. METHODS:Eighteen HIV testing sites were randomized to immediate versus 6-week delayed aPS. Participants were PLHIV (or index participants) and their sexual partners. Partners of index participants were contacted for HIV testing and linked to care if HIV positive. Primary outcomes were the number of partners per index participant who: 1) tested for HIV, 2) tested HIV positive and 3) enrolled in HIV care. We used generalized estimating equations to assess differences in aPS efficacy by region, testing location, gender, age and knowledge of HIV status. RESULTS:From 2013 to 2015, the study enrolled 1119 index participants, 625 of whom were in the immediate group. These index participants named 1286 sexual partners. Immediate aPS was more efficacious than delayed aPS in promoting HIV testing among partners in high compared to low HIV prevalence regions (Nyanza incidence rate ratio (IRR) 7.2; 95% confidence interval (CI) 5.4, 9.6 vs. Nairobi/Central IRR 3.4 95% CI 2.3, 4.8). Higher rates of partner HIV testing were also observed for index participants in rural/peri-urban compared to urban sites (IRR 6.6; 95% CI 4.5, 9.6 vs. IRR 3.5 95% CI 2.5, 5.0 respectively), for female versus male index participants (IRR 5.8 95% CI 4.2, 7.9 vs. IRR 3.7; 95% CI 2.4, 5.8 respectively) and for newly diagnosed versus known HIV-positive index participants (IRR 6.0 95% CI 4.2, 8.7 vs. IRR 3.3; 95% CI 2.0, 7.7 respectively). Providing aPS to female versus male index participants also had a significantly higher HIV case finding rate (IRR 9.1; 95% CI 4.0, 20.9 vs. IRR 3.2 95% CI 1.7, 6.0 respectively.) CONCLUSIONS: While it is known that aPS promotes increases in HIV testing and case finding, this is the first study to demonstrate significant differences in aPS efficacy across characteristics of the index participant. Understanding these differences and their drivers will be critical as aPS is brought to scale in order to ensure all PLHIV have access to these services.

Project description:BackgroundHIV assisted partner services (aPS), or provider notification and testing for sexual and injecting partners of people diagnosed with HIV, is shown to be safe, effective, and cost-effective and was scaled up within the national HIV testing services (HTS) program in Kenya in 2016. We estimated the costs of integrating aPS into routine HTS within an ongoing aPS scale-up project in western Kenya.MethodsWe conducted microcosting using the payer perspective in 14 facilities offering aPS. Although aPS was offered to both males and females testing HIV-positive (index clients), we only collected data on female index clients and their male sex partners (MSP). We used activity-based costing to identify key aPS activities, inputs, resources, and estimated financial and economic costs of goods and services. We analyzed costs by start-up (August 2018), and recurrent costs one-year after aPS implementation (Kisumu: August 2019; Homa Bay: January 2020) and conducted time-and-motion observations of aPS activities. We estimated the incremental costs of aPS, average cost per MSP traced, tested, testing HIV-positive, and on antiretroviral therapy, cost shares, and costs disaggregated by facility.ResultsOverall, the number of MSPs traced, tested, testing HIV-positive, and on antiretroviral therapy was 1027, 869, 370, and 272 respectively. Average unit costs per MSP traced, tested, testing HIV-positive, and on antiretroviral therapy were $34.54, $42.50, $108.71 and $152.28, respectively, which varied by county and facility client volume. The weighted average incremental cost of integrating aPS was $7,485.97 per facility per year, with recurrent costs accounting for approximately 90% of costs. The largest cost drivers were personnel (49%) and transport (13%). Providers spent approximately 25% of the HTS visit obtaining MSP contact information (HIV-negative clients: 13 out of 54 min; HIV-positive clients: 20 out of 96 min), while the median time spent per MSP traced on phone and in-person was 6 min and 2.5 hours, respectively.ConclusionAverage facility costs will increase when integrating aPS to HTS with incremental costs largely driven by personnel and transport. Strategies to efficiently utilize healthcare personnel will be critical for effective, affordable, and sustainable aPS.

Project description:IntroductionIn 2007, the Cameroon Baptist Convention Health Services (CBCHS) initiated an assisted partner notification services (aPNS) public health programme to increase HIV case identification and reduce HIV incidence in the most affected regions of Cameroon. We describe large-scale implementation of aPNS and overall programmatic achievements in a resource-limited setting through 2015.MethodsCBCHS trained health advisors (HAs) from 16 CBCHS facilities and 22 non-CBCHS facilities to integrate aPNS into their existing jobs in five of the ten Cameroon regions. HAs recorded basic demographic, clinical and risk factor information from consenting index persons (IPs) and similar information about their sexual partners'/contact persons (CPs) on interview records and aPNS registers. These data were entered into an Epi-Info database. HAs provided pre-test counselling to CPs and offered them HIV testing in their home or other location. HAs educated IPs and CPs on HIV prevention and risk reduction, and referred IPs and HIV positive CPs to HIV care and treatment centres. Starting in 2014, HAs re-interviewed IPs 30 days after their initial aPNS interview to ascertain instances of social harms following partner notification. Continuous predictor and outcome variables were summarized using median and interquartile range, while categorical variables were summarized using percentages from 2007 to 2015.ResultsA total of 18,730 IPs (71% women) received aPNS over nine years. IPs identified 21,057 CPs (67% men) (mean CP/IP 1.12), of whom 12,867 (61.1%) were notified of their exposure to HIV. A total of 9202 (71.5% of notified CPs) tested for HIV, 4764 (51.8%) of whom tested HIV positive (number of IPs needed to interview = 3.9); 3112 (65.3%) HIV-positive partners were referred to HIV care and treatment centres. Of the 976 IPs receiving aPNS in 2014 to 2015, for whom follow-up data were available, 11 (1.1%) reported physical intimate partner violence from CPs. Thus, 44.3% of 1224 CPs were notified through provider referral. Of the 784 CPs who tested for HIV, 157 were newly diagnosed and the overall HIV prevalence was 41.6% (326/784).ConclusionsaPNS is feasible, can be brought to scale, yields a high level of case identification, and is infrequently associated with social harms and intimate partner violence.

Project description:BackgroundRecently, more and more men who have sex with men (MSM) look for casual partners through online dating platforms in China. However, most are unable to know their partners' HIV and other sexually transmitted diseases (STD) statuses, leading to the rapid increase in HIV infection among Chinese MSM. Effective partner notification is urgently needed to increase the risk awareness of MSM and prevent HIV and other STDs transmission. However, the traditional intervention mainly targets to the HIV-positive MSM and the effect is not promising. Our study aims to provide Internet-based partner notification, along with a series of health services for HIV-negative MSM to protect them from HIV and other STDs.MethodsA pragmatic stepped wedge cluster randomized controlled trial design is used to evaluate the effectiveness of a new intervention paradigm, which aims to reduce HIV and other STDs incidences among MSM in China. Through integrating a mobile health (mHealth) service application (app) to the current HIV and other STDs prevention and control methods, the new paradigm provides partner notification of HIV, syphilis, hepatitis B, and hepatitis C statuses. A total of 6172 MSM in 16 districts of Beijing, China will be recruited and randomized to sequentially receive partner notification intervention through the app at 6-month intervals. The primary outcomes are HIV incidence and the additional cost of the intervention. The secondary outcomes include incidences of syphilis, hepatitis B, and hepatitis C, disease transmission social networks, testing adherence, knowledge of HIV and STDs control, health self-responsibility awareness, changes of high risk behaviors and other related outcomes. The generalized linear mixed models (GLMM) will be used to analyze the differences of outcomes in the control period and in the intervention period.DiscussionWe expect that the HIV incidence will be significantly lower and the secondary outcomes will also be improved with providing health service of partner notification through mhealth intervention. The feasible and affordable public health intervention paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.Trial registrationClinicalTrials.gov, NCT04349748 . Registered on 16 April 2020.

Dataset Information

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

Publications

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

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