NCT02356185

Brief Summary

Background: Data are scarce concerning injecting drug use (IDU) and alcohol consumption among HIV-infected people on highly active antiretroviral treatment (HAART) in Cameroon. The aim of this study is to determine the prevalence of alcohol consumption and IDU among HIV-infected people on HAART; to determine sociodemographic factors associated with alcohol abuse and IDU among people on HAART; and to determine impact of alcohol consumption and IDU on adherence to HAART. Methods/Design: The investigators will conduct a cross sectional study at the Yaoundé Central Hospital in Cameroon, from February to August 2015. Using a self-report questionnaire, the investigators will include at least 1,000 HIV-infected adults (18 years or more) on HAART for at least one month coming for HIV care. The investigators will exclude pregnant women. Data collection will include sociodemographic and economic profile, alcohol consumption using Alcohol Use Disorders Identification Test, injecting drug use, adherence to HAART using visual analog scale and self-rate report. The investigators will perform sub-analysis for sex group and area of habitation. A p value \< 0.05 will be considered statistically significant. Discussion: There is a critical need of accurate estimates of the amplitude and the distribution of IDU and alcohol consumption among HIV-infected adults, in order to inform health policies maker for curbing burden of both injecting drug use and alcohol consumption among people living with HIV.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

December 24, 2014

Last Update Submit

February 15, 2015

Conditions

Keywords

Alcohol DrinkingInjecting drugAntiretroviral therapysub-Saharan Africa

Outcome Measures

Primary Outcomes (1)

  • Adherence to antiretroviral therapy

    The investigators will measure adherence to antiretroviral therapy using a linear visual analogue scale on the past month as primary method of measure

    All days up to 180 days

Secondary Outcomes (1)

  • Self-rate of adherence to antiretroviral therapy

    All days up to 180 days

Other Outcomes (2)

  • Alcohol consumption

    All days up to 180 days

  • Injecting drug use

    All days up to 180 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HIV infected people

You may qualify if:

  • aged 18 years or older
  • being for at least one month on highly active antiretroviral therapy

You may not qualify if:

  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • Johnson LF, Mossong J, Dorrington RE, Schomaker M, Hoffmann CJ, Keiser O, Fox MP, Wood R, Prozesky H, Giddy J, Garone DB, Cornell M, Egger M, Boulle A; International Epidemiologic Databases to Evaluate AIDS Southern Africa Collaboration. Life expectancies of South African adults starting antiretroviral treatment: collaborative analysis of cohort studies. PLoS Med. 2013;10(4):e1001418. doi: 10.1371/journal.pmed.1001418. Epub 2013 Apr 9.

    PMID: 23585736BACKGROUND
  • Wood E, Braitstein P, Montaner JS, Schechter MT, Tyndall MW, O'Shaughnessy MV, Hogg RS. Extent to which low-level use of antiretroviral treatment could curb the AIDS epidemic in sub-Saharan Africa. Lancet. 2000 Jun 17;355(9221):2095-100. doi: 10.1016/S0140-6736(00)02375-8.

    PMID: 10902622BACKGROUND
  • Donnell D, Baeten JM, Kiarie J, Thomas KK, Stevens W, Cohen CR, McIntyre J, Lingappa JR, Celum C; Partners in Prevention HSV/HIV Transmission Study Team. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet. 2010 Jun 12;375(9731):2092-8. doi: 10.1016/S0140-6736(10)60705-2. Epub 2010 May 26.

    PMID: 20537376BACKGROUND
  • Granich RM, Gilks CF, Dye C, De Cock KM, Williams BG. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet. 2009 Jan 3;373(9657):48-57. doi: 10.1016/S0140-6736(08)61697-9. Epub 2008 Nov 27.

    PMID: 19038438BACKGROUND
  • Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.

    PMID: 21767103BACKGROUND
  • Kato M, Granich R, Bui DD, Tran HV, Nadol P, Jacka D, Sabin K, Suthar AB, Mesquita F, Lo YR, Williams B. The potential impact of expanding antiretroviral therapy and combination prevention in Vietnam: towards elimination of HIV transmission. J Acquir Immune Defic Syndr. 2013 Aug 15;63(5):e142-9. doi: 10.1097/QAI.0b013e31829b535b.

    PMID: 23714739BACKGROUND
  • Rehm J, Parry CD. Alcohol consumption and infectious diseases in South Africa. Lancet. 2009 Dec 19;374(9707):2053. doi: 10.1016/S0140-6736(09)62150-4. No abstract available.

    PMID: 20109832BACKGROUND
  • Samet JH, Walley AY, Bridden C. Illicit drugs, alcohol, and addiction in human immunodeficiency virus. Panminerva Med. 2007 Jun;49(2):67-77.

    PMID: 17625483BACKGROUND
  • Samet JH, Horton NJ, Traphagen ET, Lyon SM, Freedberg KA. Alcohol consumption and HIV disease progression: are they related? Alcohol Clin Exp Res. 2003 May;27(5):862-7. doi: 10.1097/01.ALC.0000065438.80967.56.

    PMID: 12766632BACKGROUND
  • Marcellin F, Boyer S, Protopopescu C, Dia A, Ongolo-Zogo P, Koulla-Shiro S, Abega SC, Abe C, Moatti JP, Spire B, Carrieri MP; EVAL Study Group. Determinants of unplanned antiretroviral treatment interruptions among people living with HIV in Yaounde, Cameroon (EVAL survey, ANRS 12-116). Trop Med Int Health. 2008 Dec;13(12):1470-8. doi: 10.1111/j.1365-3156.2008.02170.x. Epub 2008 Nov 5.

    PMID: 19000156BACKGROUND
  • L'akoa RM, Noubiap JJ, Fang Y, Ntone FE, Kuaban C. Prevalence and correlates of depressive symptoms in HIV-positive patients: a cross-sectional study among newly diagnosed patients in Yaounde, Cameroon. BMC Psychiatry. 2013 Sep 22;13:228. doi: 10.1186/1471-244X-13-228.

    PMID: 24053612BACKGROUND
  • Pefura-Yone EW, Soh E, Kengne AP, Balkissou AD, Kuaban C. Non-adherence to antiretroviral therapy in Yaounde: prevalence, determinants and the concordance of two screening criteria. J Infect Public Health. 2013 Aug;6(4):307-15. doi: 10.1016/j.jiph.2013.02.003. Epub 2013 Apr 22.

    PMID: 23806707BACKGROUND
  • Azar MM, Springer SA, Meyer JP, Altice FL. A systematic review of the impact of alcohol use disorders on HIV treatment outcomes, adherence to antiretroviral therapy and health care utilization. Drug Alcohol Depend. 2010 Dec 1;112(3):178-93. doi: 10.1016/j.drugalcdep.2010.06.014. Epub 2010 Aug 11.

    PMID: 20705402BACKGROUND
  • Hendershot CS, Stoner SA, Pantalone DW, Simoni JM. Alcohol use and antiretroviral adherence: review and meta-analysis. J Acquir Immune Defic Syndr. 2009 Oct 1;52(2):180-202. doi: 10.1097/QAI.0b013e3181b18b6e.

    PMID: 19668086BACKGROUND
  • Neuman MG, Schneider M, Nanau RM, Parry C. Alcohol Consumption, Progression of Disease and Other Comorbidities, and Responses to Antiretroviral Medication in People Living with HIV. AIDS Res Treat. 2012;2012:751827. doi: 10.1155/2012/751827. Epub 2012 Mar 11.

    PMID: 22496971BACKGROUND
  • Cook RL, Sereika SM, Hunt SC, Woodward WC, Erlen JA, Conigliaro J. Problem drinking and medication adherence among persons with HIV infection. J Gen Intern Med. 2001 Feb;16(2):83-8. doi: 10.1111/j.1525-1497.2001.00122.x.

    PMID: 11251758BACKGROUND
  • Tran BX, Nguyen LT, Do CD, Nguyen QL, Maher RM. Associations between alcohol use disorders and adherence to antiretroviral treatment and quality of life amongst people living with HIV/AIDS. BMC Public Health. 2014 Jan 10;14:27. doi: 10.1186/1471-2458-14-27.

    PMID: 24411007BACKGROUND
  • Samet JH, Horton NJ, Meli S, Freedberg KA, Palepu A. Alcohol consumption and antiretroviral adherence among HIV-infected persons with alcohol problems. Alcohol Clin Exp Res. 2004 Apr;28(4):572-7. doi: 10.1097/01.alc.0000122103.74491.78.

    PMID: 15100608BACKGROUND
  • Kumar S, Jin M, Ande A, Sinha N, Silverstein PS, Kumar A. Alcohol consumption effect on antiretroviral therapy and HIV-1 pathogenesis: role of cytochrome P450 isozymes. Expert Opin Drug Metab Toxicol. 2012 Nov;8(11):1363-75. doi: 10.1517/17425255.2012.714366. Epub 2012 Aug 8.

    PMID: 22871069BACKGROUND
  • von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Bull World Health Organ. 2007 Nov;85(11):867-72. doi: 10.2471/blt.07.045120.

    PMID: 18038077BACKGROUND
  • Fiellin DA, Reid MC, O'Connor PG. Screening for alcohol problems in primary care: a systematic review. Arch Intern Med. 2000 Jul 10;160(13):1977-89. doi: 10.1001/archinte.160.13.1977.

    PMID: 10888972BACKGROUND
  • Cheng DM, Libman H, Bridden C, Saitz R, Samet JH. Alcohol consumption and lipodystrophy in HIV-infected adults with alcohol problems. Alcohol. 2009 Feb;43(1):65-71. doi: 10.1016/j.alcohol.2008.09.004.

    PMID: 19185212BACKGROUND

Related Links

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Jean Joel R Bigna, MD

    Goulfey Health District Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Joel R Bigna, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Officer

Study Record Dates

First Submitted

December 24, 2014

First Posted

February 5, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 18, 2015

Record last verified: 2015-02