NCT02439918

Brief Summary

Kinshasa, Democratic Republic of Congo (DRC), is where human immunodeficiency virus type 1 (HIV-1) appears to have most diversified. The factors that lead to jumpstarting the HIV-1 epidemic remain unclear; mounting evidence suggests medical interventions may have contributed. Hepatitis C virus (HCV) and human T-cell lymphotropic virus type 1 (HTLV-1) are viruses compatible with long-term survival but with broadly similar modes of transmission as HIV. The main objective was to assess the association of past intravenous treatment with HCV and HTLV-1 seropositivity. The investigators hypothesized that medical interventions in the mid-20th century may have facilitated the emergence of HIV-1 in central Africa. To assess the association of injectable treatments with HCV and HTLV-1 infection and to reconstruct past virus dynamics, the investigators conducted a cross-sectional study of 839 elderly long-term inhabitants of Kinshasa, with serological assays followed by amplification and sequencing. Risk factors were assessed through logistic regression. Phylogenetic methods were used to reconstruct the epidemic history of HCV.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
839

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
Last Updated

May 12, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

April 29, 2015

Last Update Submit

May 6, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • HCV serology

    2 months

Secondary Outcomes (1)

  • HTLV-1 serology

    2 months

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will attempt to recruit into this cross-sectional study participants aged 70 years or more living in various districts of Kinshasa. According to countrywide demographic data, 1.4% of the Congolese population is aged 70 years or more.40 Assuming that the population of Kinshasa is around 8 million, and that the proportion of elderly is similar to that of the whole country, there could be within the capital approximately 112.000 residents aged 70 years or more. As we are interested in documenting the mechanisms of virus transmission within the city itself, we will enrol only individuals who have lived in Kinshasa for at least 35 years.

You may qualify if:

  • age ≥70 years
  • having resided in Kinshasa for ≥ 30 years
  • willingness to consent

You may not qualify if:

  • dementia or aphasia
  • inability to understand Lingala.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Gao F, Bailes E, Robertson DL, Chen Y, Rodenburg CM, Michael SF, Cummins LB, Arthur LO, Peeters M, Shaw GM, Sharp PM, Hahn BH. Origin of HIV-1 in the chimpanzee Pan troglodytes troglodytes. Nature. 1999 Feb 4;397(6718):436-41. doi: 10.1038/17130.

    PMID: 9989410BACKGROUND
  • Keele BF, Van Heuverswyn F, Li Y, Bailes E, Takehisa J, Santiago ML, Bibollet-Ruche F, Chen Y, Wain LV, Liegeois F, Loul S, Ngole EM, Bienvenue Y, Delaporte E, Brookfield JF, Sharp PM, Shaw GM, Peeters M, Hahn BH. Chimpanzee reservoirs of pandemic and nonpandemic HIV-1. Science. 2006 Jul 28;313(5786):523-6. doi: 10.1126/science.1126531. Epub 2006 May 25.

    PMID: 16728595BACKGROUND
  • Worobey M, Gemmel M, Teuwen DE, Haselkorn T, Kunstman K, Bunce M, Muyembe JJ, Kabongo JM, Kalengayi RM, Van Marck E, Gilbert MT, Wolinsky SM. Direct evidence of extensive diversity of HIV-1 in Kinshasa by 1960. Nature. 2008 Oct 2;455(7213):661-4. doi: 10.1038/nature07390.

    PMID: 18833279BACKGROUND
  • Peeters M, Toure-Kane C, Nkengasong JN. Genetic diversity of HIV in Africa: impact on diagnosis, treatment, vaccine development and trials. AIDS. 2003 Dec 5;17(18):2547-60. doi: 10.1097/01.aids.0000096895.73209.89. No abstract available.

    PMID: 14685049BACKGROUND
  • Zhu T, Korber BT, Nahmias AJ, Hooper E, Sharp PM, Ho DD. An African HIV-1 sequence from 1959 and implications for the origin of the epidemic. Nature. 1998 Feb 5;391(6667):594-7. doi: 10.1038/35400.

    PMID: 9468138BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Laboratory assays Dry blood spots were made from capillary blood deposited on Whatman 3 filter paper (serology) and Whatman Protein Saver Card (molecular biology). To document our two main outcomes (HCV and HTLV-1 infections), serological assays were performed as detailed in Web extra material, Appendix. For HCV, PCR amplification of the NS5b (485-nt) and core/E1 (1026-nt) genome regions was attempted on reactive samples. For HTLV-1, the gp21 env gene was amplified (885-nt).

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jacques Pépin, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 12, 2015

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 12, 2015

Record last verified: 2015-04