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NCT Number: NCT00941876

Integration of Family Planning and HIV Services in Tanzania

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muhimbili University of Health and Allied Services

Dar es Salaam, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Treatment and study plan

Facilitated Referral

Behavioral

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

Primary outcomes

  1. Proportion of female CTC clients with unmet need for contraception

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

Secondary outcomes

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

    Time frame: Three months after full implementation of intervention

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

    Time frame: Three months after full implementation of intervention

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

    Time frame: Three months after full implementation of intervention

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

    Time frame: Three months after full implementation of intervention

  5. Proportion of female CTC clients who are accompanied to FP services

    Time frame: Three months after full implementation of intervention

  6. Proportion of female CTC clients who receive a FP method same-day or make an appointment for sterilization

    Time frame: Three months after full implementation of intervention

  7. Proportion of referrals to FP services that are tracked by the FP clinic

    Time frame: Three months after full implementation of intervention

  8. Incremental cost per clinic of adding facilitated referral process for FP to existing CTC services

    Time frame: First month of implementation

  9. Descriptive data on the experiences and perception of CTC and FP providers and supervisors on how the facilitated referral for FP was feasible and effective within CTC services

    Time frame: Three months after full implementation of intervention

Sponsors and collaborators

Lead sponsor

FHI 360

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Official study title

An Evaluation of Integration of Family Planning Into HIV/AIDS Care and Treatment Clinics in Tanzania

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 20, 2009
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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