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

Implementation Science

Carey Farquhar⁶  Danielle Poole⁵  Felix Abuna Otieno⁸  Mable Jerop⁸  Paul Macharia⁴  Peter Maingi Mutiti¹  Ruanne Barnabas⁶  Anne Ng’ang’a⁴  Barbra Richardson⁶  David Bukusi¹  Matthew Dunbar⁷  Matthew Golden²  Peter Cherutich⁴  Laura Kelly Erdman³  Beatrice Muthoni Wamuti⁸ 

[1] VCT and HIV Prevention Unit, Kenyatta National Hospital, Hospital Road, Upper Hill 00202, Nairobi, Kenya;Public Health–Seattle & King County HIV/STD Program, 401 5th Ave, Suite 1152, Seattle 98104, WA, USA;Department of Pediatrics, University of Toronto, Hospital for Sick Children, 555 University Avenue, Toronto M5G 1X8, ON, Canada;NASCOP, Ministry of Health, Government of Kenya, Kenyatta National Hospital Grounds, Nairobi, Kenya;Department of Global Health and Population, Harvard University, 655 Huntington Avenue, Boston 02115, MA, USA;Department of Global Health, University of Washington, 1510 NE San Juan Road, Seattle 98195-7965, WA, USA;Center for Studies in Demography and Ecology, University of Washington, 206 Raitt Hall, Seattle 98195-3412, WA, USA;Department of Research and Programs, Kenyatta National Hospital, Hospital Road, Upper Hill 00202, Nairobi, Kenya

关键词: Kenya;    Sub-Saharan Africa;    Health advisors;    HIV testing and counselling;    Linkage to care;    Contact tracing;    Assisted partner notification;    HIV;   

Others  :  1133680
DOI  :  10.1186/s13012-015-0212-6

 received in 2014-12-18, accepted in 2015-01-22,  发布年份 2015

【 摘 要 】

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 webcite.

【 授权许可】

   
2015 Wamuti et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]Farquhar C, Kiarie JN, Richardson BA, Kabura MN, John FN, Nduati RW, et al.: Antenatal couple counseling increases uptake of interventions to prevent HIV-1 transmission. J Acquir Immune Defic Syndr. 2004, 37:1620-6.
• [2]Fonner VA, Denison J, Kennedy CE, O’Reilly K, Sweat M: Voluntary counseling and testing (VCT) for changing HIV-related risk behavior in developing countries. Cochrane Database Syst Rev. 2012, 9:CD001224.
• [3]Marks G, Crepaz N, Janssen RS: Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS. 2006, 20:1447-50.
• [4]Marks G, Crepaz N, Senterfitt JW, Janssen RS: Meta-analysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the United States: implications for HIV prevention programs. J Acquir Immune Defic Syndr. 2005, 39:446-53.
• [5]Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al.: Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011, 365:493-505.
• [6]UNAIDS: Global HIV/AIDS response: epidemic update and health sector progress towards universal access: progress report 2011. http://www.unaids.org/sites/default/files/media_asset/20111130_UA_Report_en_1.pdf. Accessed 1 March 2014.
• [7]Hogben M, McNally T, McPheeters M, Hutchinson AB: The effectiveness of HIV partner counseling and referral services in increasing identification of HIV-positive individuals a systematic review. Am J Prev Med. 2007, 33:S89-100.
• [8]Varghese B, Peterman TA, Holtgrave DR: Cost-effectiveness of counseling and testing and partner notification: a decision analysis. AIDS. 1999, 13:1745-51.
• [9]National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (US), Division of STD Prevention, Centers for Disease Control and Prevention (US): Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR Recommendations and Reports: Morbidity and Mortality Weekly Report Recommendations and reports/centers for disease control 2008, 57:1-83. quiz CE81-84
• [10]Henley C, Forgwei G, Welty T, Golden M, Adimora A, Shields R, et al.: Scale-up and case-finding effectiveness of an HIV partner services program in Cameroon: an innovative HIV prevention intervention for developing countries. Sex Transm Dis. 2013, 40:909-14.
• [11]Brown LB, Miller WC, Kamanga G, Nyirenda N, Mmodzi P, Pettifor A, et al.: HIV partner notification is effective and feasible in sub-Saharan Africa: opportunities for HIV treatment and prevention. J Acquir Immune Defic Syndr. 2011, 56:437-42.
• [12]NASCOP Kenya AIDS indicator survey. 2012. http://nascop.or.ke/3D/simupubs.php. Accessed 10 March 2014.
• [13]Ng’ang’a A, Waruiru W, Ngare C, Ssempijja V, Gachuki T, Njoroge I, et al.: The status of HIV testing and counseling in Kenya: results from a nationally representative population-based survey. J Acquir Immune Defic Syndr. 2014, 66(Suppl 1):S27-36.
• [14]NASCOP. HTC publications. 2014. http://nascop.or.ke/htcpubs.php. Accessed 23 March 2014.
• [15]NASCOP. Antiretroviral therapy publications: care and treatment, basic package of support and care. 2014. http://nascop.or.ke/artpubs.php. Accessed 12 April 2014.
• [16]NASCOP. Kenya HIV prevention revolution road map. 2014. http://www.nacc.or.ke/attachments/article/418/Kenya_HIV_Prevention_Revolution_Road_Map.pdf. Accessed 2 December 2014.
• [17]Holmes KK, Sparling PF, Stamm WE, Piot P, Wasserheit JH, Corey L, et al.: Sexually transmitted diseases. 4th edition. McGraw-Hill Medical, New York; 2008.
• [18]Centers for Disease Control and Prevention. Intimate partner violence. 2014. www.cdc.gov/violenceprevention/intimatepartnerviolence/index.html. Accessed 1 April 2014.
• [19]UNAIDS. Costing guidelines for HIV prevention strategies. 2000. http://data.unaids.org/publications/irc-pub05/jc412-costguidel_en.pdf. Accessed 4 May 2014.
• [20]Barnabas R, Ying R, van Rooyen H, Murnane P, Hughes J, Baeten J, et al.: Use of HIV viral-load suppression to estimate the effect of community-wide home-based HIV counselling and testing and linkage to antiretroviral therapy on HIV incidence in South Africa: a mathematical modelling analysis. Lancet. 2013, 382:S6.
• [21]Bocour A, Renaud TC, Udeagu CC, Shepard CW: HIV partner services are associated with timely linkage to HIV medical care. AIDS. 2013, 27:2961-3.
• [22]Rutstein SE, Brown LB, Biddle AK, Wheeler SB, Kamanga G, Mmodzi P, et al.: Cost-effectiveness of provider-based HIV partner notification in urban Malawi. Health Policy Plan. 2014, 29:115-26.
• [23]Menzies N, Abang B, Wanyenze R, Nuwaha F, Mugisha B, Coutinho A, et al.: The costs and effectiveness of four HIV counseling and testing strategies in Uganda. AIDS. 2009, 23:395-401.
• [24]UNAIDS. Country data for HIV. 2013. www.unaids.org/en/regionscountries/countries. Accessed 13 April 2014.
• [25]Armbruster B, Helleringer S, Kalilani-Phiri L, Mkandawire J, Kohler HP: Exploring the relative costs of contact tracing for increasing HIV case finding in sub-Saharan countries. J Acquir Immune Defic Syndr. 2011, 58:e29-36.
• [26]Edelman EJ, Cole CA, Richardson W, Boshnack N, Jenkins H, Rosenthal MS: Opportunities for improving partner notification for HIV: results from a community-based participatory research study. AIDS behav 2014, 18(10):1888-97. doi:10.1007/s10461-013-0692-9
• [27]Li Y, Marshall CM, Rees HC, Nunez A, Ezeanolue EE, Ehiri JE: Intimate partner violence and HIV infection among women: a systematic review and meta-analysis. J Int AIDS Soc. 2014, 17:18845.
• [28]Phillips DY, Walsh B, Bullion JW, Reid PV, Bacon K, Okoro N: The intersection of intimate partner violence and HIV in U.S. women: a review. J Assoc Nurses AIDS Care 2014, 25:S36-49.