Stage Matched Intervention to Increase Dual Method Use
| Status: | Completed |
|---|---|
| Conditions: | Contraception, Contraception, Infectious Disease, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 13 - 35 |
| Updated: | 4/21/2016 |
| Start Date: | October 1999 |
| End Date: | December 2005 |
The primary purpose of Project PROTECT was to evaluate two different intervention approaches
that encourage young women to use dual methods of contraception. The individualized
intervention is a computer assisted, fully-tailored, interactive intervention based on the
transtheoretical model of behavior change. This intervention was compared to an enhanced
standard care intervention that provided computer-based, non-tailored information and advice
regarding the use of contraceptive methods. The two primary outcomes of this trial include:
1) a behavioral outcome: the reported use of dual methods of contraception; and 2) a
biological outcome: an incident or recurrent STI or unintended pregnancy. The hypotheses of
this trial were: 1) the individualized intervention will result in a greater increase in
dual contraceptive use than the standard care approach; and 2) the individualized
intervention would result in greater protection against incident or recurrent cases of
sexually transmitted infections and unplanned pregnancies.
that encourage young women to use dual methods of contraception. The individualized
intervention is a computer assisted, fully-tailored, interactive intervention based on the
transtheoretical model of behavior change. This intervention was compared to an enhanced
standard care intervention that provided computer-based, non-tailored information and advice
regarding the use of contraceptive methods. The two primary outcomes of this trial include:
1) a behavioral outcome: the reported use of dual methods of contraception; and 2) a
biological outcome: an incident or recurrent STI or unintended pregnancy. The hypotheses of
this trial were: 1) the individualized intervention will result in a greater increase in
dual contraceptive use than the standard care approach; and 2) the individualized
intervention would result in greater protection against incident or recurrent cases of
sexually transmitted infections and unplanned pregnancies.
Protection from both sexually transmitted infections (STIs), human immunodeficiency virus
(HIV), and unintended pregnancy can be achieved with the use of dual methods of
contraception. This proposal was designed to develop, implement, and evaluate the impact of
an innovative, computer-assisted stage-based individualized interactive intervention
(Individualized Intervention) based on the transtheoretical compared to enhanced standard
care counseling on the use of dual methods of contraception. Primary outcomes, including
behavioral and biological outcomes, were assessed in this randomized clinical trial of 550
high-risk women. Participants were followed at 6 month intervals for 24 months with
follow-up interviews to determine reported use of dual methods of contraception (behavioral
outcome). Clinical examinations at 12 and 24 months and with new onset of symptoms assessed
biological outcomes including incident or recurrent cases of STI and unintended pregnancy.
Secondary outcomes included intermediate outcome variables such as changes in stage of
change, processes of change, decisional balance, and self-efficacy. The primary hypotheses
of this study were: 1. the Individualized Intervention will result in increased dual
contraceptive use; 2. the Individualized Intervention will result in protection against new
cases of STIs, re-infection with sexually transmitted organisms, and unplanned pregnancies;
and 3. the Individualized Intervention will lead to the greatest changes in secondary
outcome measures. If found to be effective, the stage-matched intervention has potential for
widespread dissemination in schools, clinics, offices, and community centers to prevent
STIs/HIV and unintended pregnancy.
(HIV), and unintended pregnancy can be achieved with the use of dual methods of
contraception. This proposal was designed to develop, implement, and evaluate the impact of
an innovative, computer-assisted stage-based individualized interactive intervention
(Individualized Intervention) based on the transtheoretical compared to enhanced standard
care counseling on the use of dual methods of contraception. Primary outcomes, including
behavioral and biological outcomes, were assessed in this randomized clinical trial of 550
high-risk women. Participants were followed at 6 month intervals for 24 months with
follow-up interviews to determine reported use of dual methods of contraception (behavioral
outcome). Clinical examinations at 12 and 24 months and with new onset of symptoms assessed
biological outcomes including incident or recurrent cases of STI and unintended pregnancy.
Secondary outcomes included intermediate outcome variables such as changes in stage of
change, processes of change, decisional balance, and self-efficacy. The primary hypotheses
of this study were: 1. the Individualized Intervention will result in increased dual
contraceptive use; 2. the Individualized Intervention will result in protection against new
cases of STIs, re-infection with sexually transmitted organisms, and unplanned pregnancies;
and 3. the Individualized Intervention will lead to the greatest changes in secondary
outcome measures. If found to be effective, the stage-matched intervention has potential for
widespread dissemination in schools, clinics, offices, and community centers to prevent
STIs/HIV and unintended pregnancy.
Inclusion Criteria:
1. English-speaking
2. Sexually active with a male partner in the past 6 months
3. Desire to avoid conception for 24 months or more
4. High risk for unintended pregnancy or STI:
- Age less than 25
- Age 25 and older with:
- History of unplanned pregnancy
- History of a sexually transmitted infection
- Inconsistent use of contraception
- Other factors felt to place a patient at above average risk for unplanned
pregnancy or STI
Exclusion Criteria:
1. currently using dual methods of contraception consistently and correctly.
2. incompetent or unable to give consent;
3. currently pregnant or desires pregnancy in the next 24 months.
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