Ethical issues in a stage 1 cognitive-behavioral therapy feasibility study and trial to reduce alcohol use among HIV-infected outpatients in Western Kenya

Journal of Empirical Research on Human Research Ethics

Volumn 7, Issue 3, 2012, Pages 29-37

  Papas, Rebecca K ^a   Gakinya, Benson N ^b   Baliddawa, Joyce B ^b   Martino, Steve ^c   Bryant, Kendall J ^d   Meslin, Eric M ^e   Sidle, John E ^e  

^a BROWN UNIVERSITY   (United States)

^b MOI UNIVERSITY   (Kenya)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d National Institute for Alcohol Abuse and Alcoholism   (United States)

^e INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

AIDS; Alcohol abuse; Cognitive behavioral therapy; Ethical issues; HIV; Sub Saharan Africa

Indexed keywords

ALCOHOLISM; ARTICLE; CLINICAL TRIAL; COGNITIVE THERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRINKING BEHAVIOR; EPIDEMIC; ETHICS; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTERNATIONAL COOPERATION; KENYA; MALE; MEDICAL RESEARCH; OUTPATIENT; PHASE 1 CLINICAL TRIAL; PHASE 1 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL; RESEARCH ETHICS;

ALCOHOL DRINKING; ALCOHOLISM; BIOMEDICAL RESEARCH; CLINICAL TRIALS, PHASE I AS TOPIC; COGNITIVE THERAPY; EPIDEMICS; ETHICS, RESEARCH; FEMALE; HIV INFECTIONS; HUMANS; INTERNATIONAL COOPERATION; KENYA; MALE; OUTPATIENTS;

EID: 84864559218     PISSN: 15562646     EISSN: 15562654     Source Type: Journal    
DOI: 10.1525/jer.2012.7.3.29     Document Type: Article

References (30)

1. Anderson, E. E. & DuBois, J. M. (2007). The need for evidence- based research ethics: A review of the substance abuse literature. Drug and Alcohol Dependence, 86(2/3), 95-105.
2. Ayisi, J. G., van Eijk, A. M., ter Kuile, F. O., Kolczak, M. S., Otieno, J. A., & Misore, A. O. (2000). Risk factors for HIV infection among asymptomatic pregnant women attending an antenatal clinic in western Kenya. International Journal of STD and AIDS, 11(6), 393-401.
3. Ayuku, D., Odero, W., Kaplan, C., De Bruyn, R., & De Vries, M. (2003). Social network analysis for health and social interventions among Kenyan scavenging street children. Health Policy and Planning, 18(1), 109-118.
4. Council for International Organizations of Medical Sciences (CIOMS). (2002). International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: CIOMS.
5. Einterz, R. M., Kimaiyo, S., Mengech, H. N. K., Khwa- Otsyula, B. O., Esamai, F., Quigley, F., & Mamlin, J. J. (2007). Responding to the HIV pandemic: The power of an academic medical partnership. Academic Medicine, 82(8), 812-818.
6. Emanuel, E. J. (2008). Benefits to host countries. In E. Emanuel, R. Crouch, C. Grady, R. Lie, F. Miller, & D. Wendler (Eds.), The Oxford textbook of clinical research ethics (pp. 719-728). New York: Oxford University Press.
7. Grady, C. & Denny, C. (2008). Research involving women. In E. Emanuel, R. Crouch, C. Grady, R. Lie, F. Miller, & D. Wendler (Eds.), The Oxford textbook of clinical research ethics (pp. 407-422). New York: Oxford University Press.
8. Kadden, R. M., Cooney, N. L., Getter, H., & Litt, M. D. (1989). Matching alcoholics to coping skills or interactional therapy: Posttreatment results. Journal of Consulting and Clinical Psychology, 57(6), 698-704.
9. Kalichman, S. C., Simbayi, L. C., Vermaak, R., Cain, D., Smith, G., Mthebu, J., & Jooste, S. (2008). Randomized trial of a community-based alcohol-related HIV risk-reduction intervention for men and women in Cape Town South Africa. Annals of Behavioral Medicine, 36(3), 270-279.
10. Laws of Kenya. (2001). Penal code. Chapter 63, Subsection 226.
11. Miller, W. R., Zweben, J., & Johnson, W. R. (2005). Evidencebased treatment: Why, what, where, when and how? Journal of Substance Abuse Treatment, 29(4), 267-276.
12. National AIDS and STI Programme, Ministry of Health, Kenya. (2008). Kenya AIDS indicator survey 2007: Preliminary report. Nairobi, Kenya.
13. National AIDS Control Council, Office of the President Kenya. (2008). UNGASS 2008 country report for Kenya, NACC. Nairobi, Kenya.
14. National Bioethics Advisory Commission (NBAC). (2001). Ethical and policy issues in international research: Clinical trials in developing countries. Vol. II. Commissioned papers and staff analysis. Rockville, MD.
15. National Institutes of Health. (2012). NIH Research Portfolio Online Reporting Tools (RePORT). Available online at http://report.nih.gov/index.aspx
16. Njenga, F. G. & Kigamwa, P. A. (2005). Mental health policy and programmes in Kenya. Bulletin of the Board of International Affairs of the Royal College of Psychiatrists, 8, 12-14.
17. Omonzejele, P. F. (2008). African women as clinical research subjects: Unaddressed issue in global bioethics. Ethno- Medicine, 2(2), 121-126.
18. Papas, R. K., Belar, C. D., & Rozensky, R. H. (2004). The practice of clinical health psychology: Professional issues. In R. F. Frank, A. Baum, & J. L. Wallender (Eds.), Handbook of clinical health psychology, Volume 3: Models and perspectives in health psychology (pp. 293-319). Washington, DC: American Psychological Association.
19. Papas, R. K., Sidle, J. E., Martino, S., Baliddawa, J. B., Songole, R., Omolo, O. E. et al. (2010a). Systematic cultural adaptation of cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in western Kenya. AIDS and Behavior, 14(3), 669-678.
20. Papas, R. K., Sidle, J. E., Wamalwa, E. S., Okumu, T. O., Bryant, K. L., Goulet, J. L. et al. (2010b). Estimating alcohol content of traditional brew in western Kenya using culturally relevant methods: The case for cost over volume. AIDS and Behavior, 14(4), 836-844.
21. Papas, R. K., Sidle, J.E., Gakinya, B. N., Baliddawa, J. B., Martino, S., Mwaniki, M. M. et al. (2011). Treatment outcomes of a stage 1 cognitive-behavioral trial to reduce alcohol use among human immunodeficiency virus-infected outpatients in western Kenya. Addiction, 106(12), 2156-2166.
22. Project Match Research Group. (1997). Matching alcoholism treatments to client heterogeneity: Project MATCH posttreatment drinking outcomes. Journal of Studies on Alcohol, 58(1), 7-29.
23. Rotherman-Borus, M. J., Stein, J. A., Jiraphongsa, C., Khumtong, S., Lee, S. J., & Li, L. (2010). Benefits of family and social relationships for Thai parents living with HIV. Prevention Science, 11(3), 298-307.
24. Rounsaville, B. J., Carroll, K. M., & Onken, L. S. (2001). A stage model of behavioral therapies research: Getting started and moving on from Stage I. Clinical Psychology: Science and Practice, 8(2), 133-142.
25. Seage, G. R., III, Holte, S., Gross, M., Koblin, B., Marmor, M., Mayer, K. H., & Lenderking, W. R. (2002). Casecrossover study of partner and situational factors for unprotected sex. Journal of Acquired Immune Deficiency Syndromes, 31(4), 432-439.
26. Sidle, J. E., Were, E., Wools-Kaloustian, K., Chuani, C., Salmon, K., Tierney, W. M., & Meslin, E. M. (2006). A needs assessment to build international research ethics capacity. Journal of Empirical Research in Human Research Ethics, 1(2), 23-38.
27. Siika, A. M., Rotich, J. K., Simiyu, C. J., Kigotho, E. M., Smith, F. E., Sidle, J. E. et al. (2005). An electronic medical record system for ambulatory care of HIV-infected patients in Kenya. International Journal of Medical Informatics, 74(5), 345-355.
28. Stirratt, M. J., Remien, R. H., Smith, A., Copeland, O. Q., Dolezal, C., Kireger, D. & the SMART Couples Study Team. (2006). The role of HIV serostatus disclosure in antiretroviral medication adherence. AIDS and Behavior, 10(5), 483-493.
29. Wechsberg, W. M., Luseno, W. K., Kline, T. L., Browne, F. A., & Zule, W. A. (2010). Preliminary findings of an adapted evidence-based woman-focused HIV intervention on condom use and negotiation among at-risk women in Pretoria, South Africa. Journal of Prevention and Intervention in the Community, 38(2), 132-146.
30. World Medical Association. (2008). Declaration of Helsinki: Ethical principles for medical research involving human subjects. 59th WMA General Assembly, Seoul, Korea. Ferney- Voltaire, France: World Medical Association.