Integration of Family Planning and HIV Services in Tanzania

NCT00941876 | Completed

• 1 other identifier: 10121
• Study Type: interventional
• Target: 864
• Locations: 1 country
• Sites: 1

Brief Summary

HIV positive women and couples have broad reproductive health needs that are not always met within HIV services. The integration of family planning (FP) services into Tanzania's HIV Care and Treatment Clinics (CTC) will address the fertility desires of CTC clients and ultimately result in the reduction of unintended pregnancies and HIV incidence. One strategy for integrating FP and CTC services is to use a "facilitated referral" model. Facilitated referrals are enhanced referrals for additional services that have been used in other settings and which are the preferred intervention strategy the Government of Tanzania would like to pilot test. This study will evaluate the feasibility, effectiveness, and costs of implementing a "facilitated referrals" intervention by examining FP use among female clients attending HIV/AIDS Care and Treatment Centers. This study will measure whether there is a reduction in unmet need for contraception among female CTC clients after the facilitated referral integration intervention has been implemented.

Conditions

HIV Infection; HIV Infections

Keywords

AE; adverse event; AIDS; acquired immunodeficiency syndrome; ALT (SGPT); alanine aminotransferase; ART; antiretroviral therapy; AST (SGOT); aspartate aminotransferase; DCF; data collection forms; DMC; Data Monitoring Committee; FDA; (U.S.) Food and Drug Administration; GCP; Good Clinical Practice guidelines; HB sAg; Hepatitis B surface antigen; ICH; International Conference of Harmonisation; IND; Investigational New Drug Application; IRB; Institutional Review Board; IU; International units; mg; milligram(s); mm3; cubic millimeter(s); PCR; polymerase chain reaction; SAE; serious adverse event; µg; microgram; ULN; upper limit of the normal range; WB; Western Blot; To inform the Ministry of Health strategy for integrating FP and HIV/AIDS Care and Treatment Services in Tanzania; HIV seronegativity

Outcome Measures

Primary Outcomes (1)

• Proportion of female CTC clients with unmet need for contraception

  Before intervention begins (baseline) and 3 months after full implementation of intervention

Secondary Outcomes (9)

• Proportion of female CTC clients screened on fertility intentions and unmet need for contraception

  Three months after full implementation of intervention

• Proportion of female CTC clients provided counseling on contraception or safe pregnancy

  Three months after full implementation of intervention

• Proportion of female CTC clients who received referral slip for FP services

  Three months after full implementation of intervention

• Proportion of female CTC clients whose contraceptive use/fertility intentions are recorded on their patient record form

  Three months after full implementation of intervention

• Proportion of female CTC clients who are accompanied to FP services

  Three months after full implementation of intervention

Study Arms (1)

A. Facilitated Referral

EXPERIMENTAL

Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.

Behavioral: Facilitated Referral

Interventions

Facilitated Referral BEHAVIORAL

Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.

A. Facilitated Referral

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female clients of Care \& Treatment Clinics with CD4 counts \>100, and are WHO Stage I - III. (CTC Clients)
• Care and Treatment providers who provide services to clients (CTC Providers)
• Care and Treatment supervisors who are the immediate in-charge supervisor for the CTC clinic. (CTC supervisor)
• Family Planning providers who provide services to clients. (FP providers)
• Family Planning supervisors who are the immediate in-charge supervisor for the FP clinic. (FP supervisor)

Sponsors & Collaborators

• FHI 360: lead
• Muhimbili University of Health and Allied Sciences: collaborator

Study Sites (1)

Muhimbili University of Health and Allied Services

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Joy N Bumgartner, MSW, PhD

  FHI 360

  PRINCIPAL INVESTIGATOR

• Thecla W Kohi, PhD

  Muhimbili University of Health and Allied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 20, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 11, 2011

Record last verified: 2011-08

Locations

TA (1)