Contraceptive and Reproductive

Contraceptive and Reproductive Health Technologies
Research and Utilization Program

Quarterly Briefs, Oct-Dec 2007

Research

* Community-Based Workers Can Administer Safe, High-Quality
Contraceptive Injections
* Research from Three Developing Countries Confirms Hierarchy of
Contraceptive Effectiveness
* Risk of Pregnancy Should be Considered When Designing
Effectiveness Trials of HIV-Prevention Drugs

Research to Practice

* Family Health International Updates "Underused Research
Findings"
* Indian Government Takes Steps to Revitalize Intrauterine Device
Services
* Training on Good Clinical Practice Held in the Dominican
Republic

_____________________________________________

Research:

Community-Based Workers Can Administer Safe, High-Quality Contraceptive
Injections

Community-based reproductive health workers in a rural African setting
can provide contraceptive injections as safely and effectively as local
clinic-based workers, according to results of a USAID-supported study in
Uganda.

Community-based workers in Nakasongola district, Uganda, were trained in
counseling skills, health screening for injectable users, techniques for
safe injections, and proper waste disposal. They then spent two weeks
observing and practicing injections of depot medroxyprogesterone acetate
(DMPA) in supervised medical settings, after which they began providing
injections on their own. Job aids provided during the training included
a checklist for client screening and an illustrated counseling tool.

Scientists from Family Health International, the Uganda Ministry of
Health, and Save the Children/USA interviewed 777 clients 13 weeks after
their first contraceptive injection. The care received from the
community-based workers was compared with the care received from nurses
and midwives in local health centers. Care was evaluated according to
whether a second injection was obtained, continuation rates and reasons
for discontinuation, client satisfaction, and recall of key counseling
messages, among other measures.

Results of the study showed no significant difference in continuation
rates or client satisfaction between the two groups. Clients of the
community-based workers had a slightly higher rate of problems at the
injection site than clients of clinic-based workers, but this difference
was not significant and decreased over time (presumably because of
improved injection technique with practice). Interviewers noted that
clients in both groups had difficulty retaining key counseling messages
such as common side effects and method-related health problems for which
medical attention should be sought.

The authors of the study conclude that the practice of contraceptive
injections by community-based reproductive health workers should be
scaled up throughout Africa and elsewhere. Special emphasis should be
placed on promoting quality and access through training, the use of job
aids, and solid logistical support systems.

To read more about this topic, see:
http://www.who.int/bulletin/volumes/85/10/07-040162/en/index.html

Source
Stanback J, Mbonye AK, Bekiita M. Contraceptive injections by community
health workers in Uganda: a nonrandomized community trial. Bull World
Health Organ 2007;85(10):768-773.

Research from Three Developing Countries Confirms Hierarchy of
Contraceptive Effectiveness

Results from a recent analysis supported by USAID and the National
Institutes of Health underscore the counseling message that when it
comes to preventing pregnancy, injectable contraceptives are more
effective than combined oral contraceptive pills, which are more
effective than condoms. The analysis was conducted by scientists at
Family Health International, Makerere University in Uganda, the
University of Zimbabwe, and Chiang Mai University in Thailand, and was
based on data collected between November 1999 and January 2004.

The research involved 5,224 women from Uganda, Zimbabwe, and Thailand
who had participated in a study on the association between hormonal
contraception and HIV acquisition. Results showed that for a woman using
an injectable contraceptive, the risk that she would become pregnant
within one year of starting the method was 1 percent or less in all
three countries. In Uganda and Zimbabwe, the risk that a user of oral
contraceptive pills would become pregnant was at least 10 percent.

For women intending to use injectables, pills, or condoms at the
beginning of the study, the annual pregnancy risk for condoms was by far
the highest: as high as 30 percent in Uganda. The risk of pregnancy
among users of pills or condoms was substantially lower in Thailand than
in the African countries, but the investigators were not able to clarify
the reason for this discrepancy.

Study investigators support contraceptive counseling that clarifies the
different levels of pregnancy protection afforded by different methods,
and that informs women that their experience with a particular form of
contraception may vary from the average or typical experience.
Furthermore, the investigators urge counselors to provide women with
tailored counseling, to allow them to make more informed contraceptive
choices.

To read more about this topic, see:
http://www.ncbi.nlm.nih.gov/pubmed/17978111?dopt=Abstract

Source
Steiner MJ, et al. Pregnancy risk among oral contraceptive pill,
injectable contraceptive, and condom users in Uganda, Zimbabwe, and
Thailand. Obstet Gynecol 2007;110(5):1003-1009.

Risk of Pregnancy Should be Considered When Designing Effectiveness
Trials of HIV-Prevention Drugs

A recently published article, supported by USAID and the National
Institute of Child Health and Human Development, summarizes key issues
related to pregnancy that should be carefully considered during the
design of trials that test the effectiveness of HIV-prevention drugs.
The issues were raised during several meetings of HIV-prevention
researchers and selected experts.

Because trials that test the effectiveness of HIV-prevention drugs
require the enrollment of sexually active women of reproductive age,
study participants are simultaneously exposed to the risks of HIV and
pregnancy. The risk of pregnancy in particular has important - yet often
complicated - implications for how trials are conducted, and how data
are interpreted.

For example, trial organizers need to protect participants by preventing
pregnancies or by identifying pregnancies before a fetus is
unnecessarily exposed to a study drug. Preventing pregnancies is also
important because the results of a trial can be skewed when pregnant
women stop taking a study drug. Yet lack of access to contraception can
be a problem. Also, some contraceptive methods could alter the
effectiveness of a study drug, or their side effects could mimic a
drug's toxic effects.

Other major issues identified during the meetings include ensuring the
safety of trial participants; concerns related to the interpretation of
data when participants become pregnant; strategies for preventing
pregnancy; and the reliable, safe identification and care of pregnant
women during trials.

To read more about this topic, see:
http://www.popline.org/docs/322525

Sources
Raymond EG, Taylor D, Cates W, et al. Pregnancy in effectiveness trials
of HIV prevention agents. Sex Transm Dis 2007;34(12):1035-1039.

___________________________________________

Research to Practice:

Family Health International Updates "Underused Research Findings"

As part of its USAID-supported Research to Practice Initiative, Family
Health International (FHI) has updated its working summary of "underused
research findings."

These are findings from research and programs that FHI believes would
improve family planning and reproductive health services if they were
more widely incorporated into policies and programs in the developing
world.

Updated in November 2007, the new summary covers 16 topics - including
five new ones on youth, implants, contraceptive continuation, male
circumcision and HIV, and contraceptive counseling and job aids. FHI is
committed to promoting use of the full summary of findings, which can be
found at:
http://www.fhi.org/en/RH/Programs/RtoP/underusedres.htm

Indian Government Takes Steps to Revitalize Intrauterine Device Services

With support from USAID, Family Health International recently conducted
a technical symposium aimed at developing strategies to expand
intrauterine device (IUD) services in India. The symposium was held in
Lucknow, India on October 3-4, 2007.

Additional partners in the efforts to revitalize IUD services in India
include USAID, the Indian Ministry of Health and Human Welfare, the
government of Uttar Pradesh, Constella Futures, the State Innovations in
Family Planning Services Project Agency, JHPIEGO, and the Population
Council.

The symposium welcomed 65 participants, including senior ministry and
government officials, representatives from sponsors and nongovernmental
organizations, as well as public and private practitioners. Program
participants represented areas crucial to the conference goals, with
expertise in clinical care, research, capacity building, program
implementation, information, education, and communication.

Symposium participants recommended the following strategies for
expanding IUD services:

* Service delivery can be improved by supervising providers in a
facilitative, not punitive, manner; by insuring that providers are
recognized based on superior performance; and by working to increase the
rate of IUD provision in the immediate post-partum period.

* Improving human resources will require competency-based
training. Monitoring is also needed to insure that this type of training
is consistently translated into actual practice. Furthermore,
educational programs for medical personnel at all levels should
emphasize family planning methods, particularly the IUD.

* Well-designed community-awareness campaigns should be the focus
of communication efforts to change behaviors. Additionally, all
categories of IUD providers should receive comprehensive training to
improve their communication and counseling skills.

* Public-private partnerships will need to be strengthened,
perhaps using the successes of the Hindustan Latex Family Planning
Promotion Trust as a model. Multiple channels and associations should be
employed in an effort to improve on the general awareness of family
planning and IUDs. This may be accomplished by studying those factors
that further motivate private-sector involvement in IUD services, as
well as by engaging the Federation of Obstetrics and Gynecology
Societies of India in the training and quality improvement of private
providers.

To find out more about this topic, see:
http://www.maqweb.org/iudtoolkit/index.shtml

Training on Good Clinical Practice Held in the Dominican Republic

Forty-six nurses and physicians affiliated with Profamilia in the
Dominican Republic participated in a USAID-supported training on Good
Clinical Practice (GCP) on October 13, 2007. Good Clinical Practice is a
set of international standards that pertain to clinical trials involving
human subjects.

Led by Family Health International, the training covered topics
essential to conducting trials according to GCP regulations of the U.S.
Food and Drug Administration and the GCP guidelines of The International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use.

Topics discussed during the training included:

* Principles of GCP
* Responsibilities of trial investigators
* Source documentation (i.e., all of the original documents, data,
and records generated during the course of a trial)
* Responsibilities of institutional review boards
* Responsibilities of sponsors
* Clinical study protocols
* Investigator brochures
* Essential documents (i.e., those that help in evaluating how a
study is conducted and determining the quality of the data produced)

Family Health International offers courses on GCP to train its sponsors
and partner organizations on how to conduct ethical trials. Profamilia
provides extensive services throughout the Dominican Republic, including
a full range of family planning activities, a very successful
social-marketing program, and a biomedical and demographic research
project.

For more information about the foundations of research ethics, including
GCP, see:
http://www.fhi.org/training/en/Retc/s2pg8.htm