NCT02606344

Brief Summary

The high rates of HIV infection in women have brought into sharp focus the problem of violence against women. There is a growing recognition that women and girls' risk of and vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities violence against them in particular. The links between intimate partner violence and HIV/AIDS are explained by biological as well as sociocultural and economic factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
561

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

1.1 years

First QC Date

November 13, 2015

Last Update Submit

November 13, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of New Sexually Transmitted Infections

    12 months

Secondary Outcomes (2)

  • Proportion of women Reporting Physical, Sexual, or Psychological Partner Violence

    12 Months

  • Proportion of unprotected sexual acts with partner

    12 month

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

Loans were provided to poor women who enrolled in the intervention group. A participatory learning and action curriculum was integrated into loan meetings, which took place every 2 weeks.

Other: Mico-finance based intervention

Control Group (CG)

NO INTERVENTION

Interventions

Intervention Group (IG)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years old;
  • Must plan to reside in study areas for the next 12 months
  • Must visit camp at least 1 time per week
  • Must provide contact information of friend or family member

You may not qualify if:

  • Unwilling to provide local information
  • Psychological disturbance, cognitive impairment or threatening behavior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sonal Foundation

Mahesāna, Gujarat, 384001, India

Location

Vinita Nursing Home

Hindaun, Rajasthan, India

Location

NMP Medical Research Institute

Deharadun, Uttarakhand, India

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Kalvinder Kour, MBA

    NMP Medical Research Institute, India

    PRINCIPAL INVESTIGATOR
  • Neha Sharma, PhD

    Macmillan Research Group UK

    STUDY DIRECTOR
  • Vinita Makkad, MD

    Vinita Nursing Home, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 17, 2015

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations