Epidemiological and Clinical Description of Women Living With HIV in Selected Countries of Latin America

NCT04605354 | Unknown

• 1 other identifier: Women living with HIV in LATAM
• Study Type: observational
• Target: 25,816
• Locations: 1 country
• Sites: 1

Brief Summary

A cross-sectional study that uses ecological data from (1) PLWHIV under care at 31st December 2017, and (2) from yearly admissions to care occurred during 2013 - 2017, from centers belonging to LAW-HIV.

Conditions

HIV-1-infection; Hiv

Keywords

Women; Latin America

Outcome Measures

Primary Outcomes (2)

• Epidemiological and clinical description of women that receive HIV care in selected countries of Latin America.

  1.1. In women admitted to care between years 2013-2017, the trend in the: * distribution of ages; * proportion of late presenters (CD4). * proportion that start ART during the first year after admission; * schemes of ART used for the first ART. 1.2. Proportion of women alive, retained to care, retained to ART, and with virologic suppression at one year of follow up, from admissions occurred in 2016.

  1 year

• Management of HIV infection during pregnancy in women from selected countries of Latin America.

  2\. In women that finished their pregnancy at any moment during 2019: * Proportion with HIV diagnosis as consequence of the pregnancy. * Earliest CD4 level. * Proportion that suspended ART during pregnancy * Frequency of each scheme of ART used previous the conception * Change of scheme of ART * Proportion whose pregnancy ended in term * Proportion retained in care during the first 6 months after pregnancy * Proportion that suspended breastfeeding during the first 3 months after pregnancy

  1 year

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For the overall aim 1, the investigators expected to include information about 25,816 women under care, and between 6,000 and 7,500 women admitted during 2013 - 2017 (depending on the sub-analysis), from 14 countries and 79 centers. For the overall aim 2, the investigators expect to include aggregated information from roughly 400 pregnant females, from at least ten countries. It is worth noticing that the analytic unit corresponds to the information at the stratum level and depending on the disposition of the information in the database, the total numbers of strata will vary between approximately 400 to 8.000.

* All Latin American HIV care centers from any Spanish speaking country are invited to participate in the LAW-HIV. * Only centers that provide a minimum of information (at least sections 1 and 2 from the datasheet for aim 1) will be included in the analysis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Helios Salud: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Helios Salud

Buenos Aires, C1141, Argentina

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Isabel Cassetti, MD

  Helios Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: October 28, 2020
• Study Start: July 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

AR (1)