NCT01903889

Brief Summary

The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment (C\&T) services. In 4 health centers, a basic intervention is introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women. They are charged with counseling C\&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods. In the other 4 health centers, the basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services. This includes training of C\&T providers on gender-based influences on health behaviors; provision of couples' HIV testing and FP counseling services; and community-based education for men to promote gender equitable norms and male participation in health services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,806

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

7 active sites

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

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

July 17, 2013

Last Update Submit

January 8, 2015

Conditions

Keywords

AE adverse eventAIDS acquired immunodeficiency syndromeALT (SGPT) alanine aminotransferaseART antiretroviral therapyAST (SGOT) aspartate aminotransferaseDCF data collection formsDMC Data Monitoring CommitteeFDA (U.S.) Food and Drug AdministrationGCP Good Clinical Practice guidelinesHB sAg Hepatitis B surface antigenICH International Conference of HarmonizationIND Investigational New Drug ApplicationIRB Institutional Review BoardIU International unitsmg milligram(s)mm3 cubic millimeter(s)PCR polymerase chain reactionSAE serious adverse eventµg microgramULN upper limit of the normal rangeWB Western BlotANC Antenatal careARV AntiretroviralC&T Care and treatmentCPR Contraceptive prevalence rateDHS Demographic and Health SurveyEGPAF Elizabeth Glaser Pediatric AIDS FoundationFP Family planningHIV Human immunodeficiency virusHTC HIV testing and counselingIUCD Intrauterine contraceptive deviceMCH Maternal/child healthPDA Personal digital assistantPEPFAR President's Emergency Plan for AIDS ReliefPHSC Protection of Human Subjects CommitteePMTCT Prevention of maternal to child transmissionSTAR-SW Strengthening TB and HIV/AIDS Response in the South Western Region of UgandaSTI Sexually transmitted infectionTM Technical monitorUSAID United States Agency for International DevelopmentWHO World Health Organization

Outcome Measures

Primary Outcomes (1)

  • To assess the effectiveness of an intervention aimed at constructively engaging men in FP decision making

    Dual method use among couples with at least one partner using C\&T services

    12 months

Secondary Outcomes (5)

  • To measure changes over time in uptake of Prong 3 PMTCT services, comparing facilities that are and are not exposed to the constructive male engagement intervention

    6 months

  • To assess the effect of reinforcements introduced to enhance C&T providers' capacity to serve the FP needs of HIV-positive clients, as reflected in C&T clients' knowledge, attitudes, and behaviors related to FP.

    12 months

  • To explore condom use dynamics and the factors favoring and discouraging consistent use by cohabiting couples

    1 month

  • To evaluate men's knowledge and attitudes related to gender norms and FP and HIV services before and after participation in a 10-week community education and mobilization program.

    10 months

  • To document the technical, human, and material resources required to implement the study interventions and to estimate the financial cost of implementation at scale.

    12 months

Study Arms (2)

Clinic based intervention

ACTIVE COMPARATOR

basic intervention is introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women. They are charged with counseling C\&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods

Other: clinic based intervention

clinic and community based intervention

EXPERIMENTAL

The basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services. This includes training of C\&T providers on gender-based influences on health behaviors; provision of couples' HIV testing and FP counseling services; and community-based education for men to promote gender equitable norms and male participation in health services.

Other: clinic and community based intervention

Interventions

counseling C\&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods

Clinic based intervention

basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services

clinic and community based intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female participants
  • attending pre-ART and ART services;
  • non-pregnant women;
  • age 18 to 45;
  • sexually active with any type of partner within the past 3 months.
  • male participants
  • attending pre-ART and ART services;
  • age 18 to 60;
  • sexually active within the past 3 months with partner, either co-habiting partner or steady, with partner aged 18 to 45 and is not pregnant.

You may not qualify if:

  • For the post-intervention interviews, clients who initiated Care \& Treatment services in one of the intervention facilities less than 3 months prior will be excluded given insufficient exposure to the intervention.
  • Clients unable to speak Runyankole, the dominant language in the region, will also be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bukinda Health Center

Kabale, Uganda

Location

Kamkira Health Center

Kabale, Uganda

Location

Kamwezi Health Center

Kabale, Uganda

Location

Maziba Health Center

Kabale, Uganda

Location

Mparo Health Center

Kabale, Uganda

Location

Muko Health Center

Kabale, Uganda

Location

Rubaya Health Center

Kabale, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexually Transmitted Diseases

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Theresa Hoke, Ph.D., MPH

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 19, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations