Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial

Larry W Chang, Ismail Mbabali, Xiangrong Kong, Heidi Hutton, K Rivet Amico, Caitlin E Kennedy, Fred Nalugoda, David Serwadda, Robert C Bollinger, Thomas C Quinn, Steven J Reynolds, Ronald Gray, Maria Wawer, Gertrude Nakigozi, Larry W Chang, Ismail Mbabali, Xiangrong Kong, Heidi Hutton, K Rivet Amico, Caitlin E Kennedy, Fred Nalugoda, David Serwadda, Robert C Bollinger, Thomas C Quinn, Steven J Reynolds, Ronald Gray, Maria Wawer, Gertrude Nakigozi

Abstract

Background: Effective yet practical strategies are needed to increase engagement in HIV treatment and prevention services, particularly in high-HIV-prevalence hotspots. We designed a community-based intervention called "Health Scouts" to promote uptake and adherence to HIV services in a highly HIV-prevalent fishing community in Rakai, Uganda. Using a situated Information, Motivation, and Behavioral skills theory framework, the intervention consists of community health workers, called Health Scouts, who use motivational interviewing strategies and mobile health tools to promote engagement in HIV treatment and prevention services.

Methods/design: The Health Scout intervention is being evaluated through a pragmatic, parallel, cluster-randomized controlled trial with an allocation ratio of 1:1. The study setting is a single high-HIV-prevalence fishing community in Rakai, Uganda divided into 40 contiguous neighborhood clusters each containing about 65 households. Twenty clusters received the Health Scout Intervention; 20 clusters received standard of care. The Health Scout intervention is delivered within the community at the household level, targeting all residents aged 15 years or older. The primary programmatic outcomes are self-reported HIV care, antiretroviral therapy, and male circumcision coverage; the primary biologic outcome is population-level HIV viremia prevalence. Follow-up is planned for about 3 years.

Discussion: HIV treatment and prevention service engagement remains suboptimal in HIV hotspots. New, community-based implementation approaches are needed. If found to be effective in this trial, the Health Scout intervention may be an important component of a comprehensive HIV response.

Trial registration: ClinicalTrials.gov, ID: NCT02556957 . Registered on 20 September 2015.

Keywords: Adherence; Antiretroviral therapy; Community health workers; HIV; Male circumcision; Motivational interviewing; Randomized controlled trial; Uganda; mHealth.

Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by the Research and Ethics Committee of the Uganda Virus Research Institute (GC/127/16/06/505), the Ugandan Council of Science and Technology (SS 3868), the Western Institutional Review Board (20031318), and the Johns Hopkins School of Medicine Institutional Review Board (IRB00062089). All participants provided oral and written consent and assent as appropriate.

Consent for publication

Not applicable.

Competing interests

emocha Mobile Health Inc. is the company that developed and supported the smartphone application used in this protocol. LC and RB are entitled to royalties on certain non-research revenue generated by this company and own company equity. Specific to this study, LC and RB have and will receive no royalties or compensation from emocha Mobile Health Inc. This arrangement has been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies. LC and RB will not be members of the DMC established for this study. All other study team members have no known competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The mHealth Lakefolk Actively Keeping Engaged (mLAKE) study flow diagram
Fig. 2
Fig. 2
mHealth Lakefolk Actively Keeping Engaged (mLAKE) trial cluster map (intervention: clear, control; grayed)
Fig. 3
Fig. 3
PRECIS-2 wheel for the mHealth Lakefolk Actively Keeping Engaged (mLAKE) trial
Fig. 4
Fig. 4
Health Scout intervention conceptual framework
Fig. 5
Fig. 5
Example screenshots from Health Scout smartphone application
Fig. 6
Fig. 6
Example of counseling module flow and content: HIV-positive, not yet in care
Fig. 7
Fig. 7
SPIRIT Figure; the mHealth Lakefolk Actively Keeping Engaged (mLAKE) trial schedule of enrollment, interventions, and assessments

References

    1. Kurth A, Celum C, Baeten J, Vermund S, Wasserheit J. Combination HIV prevention: significance, challenges, and opportunities. Curr HIV/AIDS Rep. 2011;8(1):62–72. doi: 10.1007/s11904-010-0063-3.
    1. Piot P, Bartos M, Larson H, Zewdie D, Mane P. Coming to terms with complexity: a call to action for HIV prevention. Lancet. 2008;372(9641):845–59. doi: 10.1016/S0140-6736(08)60888-0.
    1. Wilson DP. HIV Treatment as prevention: natural experiments highlight limits of antiretroviral treatment as HIV prevention. PLoS Med. 2012;9(7):e1001231. doi: 10.1371/journal.pmed.1001231.
    1. UNAIDS . Report on the Global AIDS Epidemic. Geneva: UNAIDS; 2013.
    1. Smith MK, Powers KA, Muessig KE, Miller WC, Cohen MS. HIV treatment as prevention: the utility and limitations of ecological observation. PLoS Med. 2012;9(7):e1001260. doi: 10.1371/journal.pmed.1001260.
    1. Chang LW, Serwadda D, Quinn TC, Wawer MJ, Gray RH, Reynolds SJ. Combination implementation for HIV prevention: moving from clinical trial evidence to population-level effects. Lancet Infect Dis. 2013;13(1):65–76. doi: 10.1016/S1473-3099(12)70273-6.
    1. Granich R, Gupta SB, Suthar A, Smyth C, Hoos D, Vitoria M, Simao M, Hankins C, Schwartlander B, Ridzon R, et al. Antiretroviral therapy in prevention of HIV and TB: update on current research efforts. Curr HIV Res. 2011;9(6):446–69. doi: 10.2174/157016211798038597.
    1. Clift S, Anemona A, Watson-Jones D, Kanga Z, Ndeki L, Changalucha J, Gavyole A, Ross DA. Variations of HIV and STI prevalences within communities neighbouring new goldmines in Tanzania: importance for intervention design. Sex Transm Infect. 2003;79(4):307–12. doi: 10.1136/sti.79.4.307.
    1. Kimani J, McKinnon LR, Wachihi C, Kusimba J, Gakii G, Birir S, Muthui M, Kariri A, Muriuki FK, Muraguri N, et al. Enumeration of sex workers in the central business district of Nairobi, Kenya. PloS One. 2013;8(1):e54354. doi: 10.1371/journal.pone.0054354.
    1. Kiwanuka N, Ssetaala A, Mpendo J, Wambuzi M, Nanvubya A, Sigirenda S, Nalutaaya A, Kato P, Nielsen L, Kaleebu P, et al. High HIV-1 prevalence, risk behaviours, and willingness to participate in HIV vaccine trials in fishing communities on Lake Victoria, Uganda. J Int AIDS Soc. 2013;16(1):18621. doi: 10.7448/IAS.16.1.18621.
    1. Messina JP, Emch M, Muwonga J, Mwandagalirwa K, Edidi SB, Mama N, Okenge A, Meshnick SR. Spatial and socio-behavioral patterns of HIV prevalence in the Democratic Republic of Congo. Soc Sci Med. 2010;71(8):1428–35. doi: 10.1016/j.socscimed.2010.07.025.
    1. Opio A, Muyonga M, Mulumba N. HIV infection in fishing communities of Lake Victoria Basin of Uganda—a cross-sectional sero-behavioral survey. PLoS One. 2013;8(8):e70770. doi: 10.1371/journal.pone.0070770.
    1. Peng ZH, Cheng YJ, Reilly KH, Wang L, Qin QQ, Ding ZW, Ding GW, Ding KQ, Yu RB, Chen F, et al. Spatial distribution of HIV/AIDS in Yunnan province, People’s Republic of China. Geospat Health. 2011;5(2):177–82. doi: 10.4081/gh.2011.169.
    1. Wand H, Ramjee G. Targeting the hotspots: investigating spatial and demographic variations in HIV infection in small communities in South Africa. J Int AIDS Soc. 2010;13:41. doi: 10.1186/1758-2652-13-41.
    1. Barnighausen T, Tanser F. Rethinking the role of the local community in HIV epidemic spread in sub-Saharan Africa: a proximate-determinants approach. HIV Ther. 2009;3(5):435–45. doi: 10.2217/hiv.09.33.
    1. Tanser F, Barnighausen T, Cooke GS, Newell ML. Localized spatial clustering of HIV infections in a widely disseminated rural South African epidemic. Int J Epidemiol. 2009;38(4):1008–16. doi: 10.1093/ije/dyp148.
    1. UNAIDS . The Gap Report. 2014.
    1. The Economist. The 20th International AIDS Conference: Is the end in sight? The Economist; 2014.
    1. UNAIDS . Getting to Zero 2011–2015 Strategy. Geneva: UNAIDS; 2010.
    1. PEPFAR . Report to Congress on Prevention. 2010.
    1. Chang LW, Grabowski MK, Ssekubugu R, Nalugoda F, Kigozi G, Nantume B, Lessler J, Moore SM, Quinn TC, Reynolds SJ, et al. Heterogeneity of the HIV epidemic in agrarian, trading, and fishing communities in Rakai, Uganda: an observational epidemiological study. Lancet HIV. 2016;3(8):e388–396. doi: 10.1016/S2352-3018(16)30034-0.
    1. Mwai GW, Mburu G, Torpey K, Frost P, Ford N, Seeley J. Role and outcomes of community health workers in HIV care in sub-Saharan Africa: a systematic review. J Int AIDS Soc. 2013;16(1):18586. doi: 10.7448/IAS.16.1.18586.
    1. Community health workers: What do we know about them? The state of the evidence on programmes, activities, costs and impact on health outcomes of using community health workers. Geneva: Evidence and Information for Policy, Department of Human Resources for Health, World Health Organization; 2007.
    1. Kohler PK, Chung MH, McGrath CJ, Benki-Nugent SF, Thiga JW, John-Stewart GC. Implementation of free cotrimoxazole prophylaxis improves clinic retention among antiretroviral therapy-ineligible clients in Kenya. AIDS. 2011;25(13):1657–61. doi: 10.1097/QAD.0b013e32834957fd.
    1. Singh P, Chokshi DA. Community health workers—a local solution to a global problem. N Engl J Med. 2013;369(10):894–6. doi: 10.1056/NEJMp1305636.
    1. Callaghan M, Ford N, Schneider H. A systematic review of task-shifting for HIV treatment and care in Africa. Hum Resour Health. 2010;8:8–16. doi: 10.1186/1478-4491-8-8.
    1. Sub-Saharan Africa Mobile Economy 2013. GMSA Intelligence; 2013. .
    1. Yonazi E, Kelly T, Halewood N, Blackman C. The transformational use of information and communication technologies in Africa. In: eTransform Africa. Washington DC, Tunis Belvedere: The World Bank and the African Development Bank, with the support of the African Union; 2012.
    1. Hill S, Kavookjian J. Motivational interviewing as a behavioral intervention to increase HAART adherence in patients who are HIV-positive: a systematic review of the literature. AIDS Care. 2012;24(5):583–92. doi: 10.1080/09540121.2011.630354.
    1. Miller WR, Rollnick S. Motivational interviewing. New York: Guilford; 1991.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.
    1. Chirowodza A, van Rooyen H, Joseph P, Sikotoyi S, Richter L, Coates T. Using participatory methods and geographic information systems (GIS) to prepare for an HIV community-based trial in Vulindlela, South Africa (Project Accept-HPTN 043) J Community Psychol. 2009;37(1):41–57. doi: 10.1002/jcop.20294.
    1. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147.
    1. Rivet AK. A situated-Information Motivation Behavioral Skills Model of Care Initiation and Maintenance (sIMB-CIM): an IMB model based approach to understanding and intervening in engagement in care for chronic medical conditions. J Health Psychol. 2011;16(7):1071–81. doi: 10.1177/1359105311398727.
    1. Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006;25(4):462–73. doi: 10.1037/0278-6133.25.4.462.
    1. Solomon SS, Mehta SH, McFall AM, Srikrishnan AK, Saravanan S, Laeyendecker O, Balakrishnan P, Celentano DD, Solomon S, Lucas GM. Community viral load, antiretroviral therapy coverage, and HIV incidence in India: a cross-sectional, comparative study. Lancet HIV. 2016;3(4):e183–190. doi: 10.1016/S2352-3018(16)00019-9.
    1. Wawer MJ, Sewankambo NK, Serwadda D, Quinn TC, Paxton LA, Kiwanuka N, Wabwire-Mangen F, Li C, Lutalo T, Nalugoda F, et al. Control of sexually transmitted diseases for AIDS prevention in Uganda: a randomised community trial. Rakai Project Study Group. Lancet. 1999;353(9152):525–35. doi: 10.1016/S0140-6736(98)06439-3.
    1. Hayes R, Moulton LH. Cluster randomised trials: Chapman and Hall/CRC. 2009.
    1. Thiessen C, Ssekubugu R, Wagman J, Kiddugavu M, Wawer MJ, Emanuel E, Gray R, Serwadda D, Grady C. Personal and community benefits and harms of research: views from Rakai, Uganda. AIDS. 2007;21(18):2493–501. doi: 10.1097/QAD.0b013e3282f029d3.
    1. Evangeli M, Engelbrecht SK, Swartz L, Turner K, Forsberg L, Soka N. An evaluation of a brief motivational interviewing training course for HIV/AIDS counsellors in Western Cape Province, South Africa. AIDS Care. 2009;21(2):189–96. doi: 10.1080/09540120802002471.
    1. Dewing S, Mathews C, Schaay N, Cloete A, Simbayi L, Louw J. Improving the counselling skills of lay counsellors in antiretroviral adherence settings: a cluster randomised controlled trial in the Western Cape, South Africa. AIDS Behav. 2015;19(1):157–65. doi: 10.1007/s10461-014-0781-4.
    1. Dillard PK, Zuniga JA, Holstad MM. An integrative review of the efficacy of motivational interviewing in HIV management. Patient Educ Couns. 2017;100(4):636-46.
    1. Creswell JW, Plano Clark VL. Designing and conducting mixed methods research. Thousand Oaks: SAGE; 2011.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel